Advanced/Metastatic Head and Neck, Oesophageal and Cervical CancersPhase 2NCT03386721
Basket Study to Evaluate the Therapeutic Activity of Simlukafusp Alfa as a Combination Therapy in Participants With Advanced and/or Metastatic Solid Tumors
A Phase 2 study testing simlukafusp alfa, Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody and Gemcitabine in people with Advanced/Metastatic Head and Neck, Oesophageal and Cervical Cancers, run by Hoffmann-La Roche at 44 sites in 15 countries.
Trial summary
This is an open-label, multicenter, basket trial Phase II study to evaluate the antitumor activity of simlukafusp alfa in combination with atezolizumab in participants with advanced and/or metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced/Metastatic Head and Neck, Oesophageal and Cervical Cancers
- What is being tested?
- simlukafusp alfa, Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 44 sitesin 15 countries
- Study dates
- 19 Feb 2018to 30 Dec 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who have progressed on at least one previous regimen of anticancer therapy (chemotherapy, mutation targeted therapy, and/or CPI therapy)
- Measurable disease, as defined by RECIST Version 1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 or Karnofsky Performance Score greater than or equal to (>=) 70
- Life expectancy of >=12 weeks
- Confirmed at least one tumor lesion with location accessible to safely biopsy per clinical judgment of the treating physician.
- Biopsies are not applicable to participants in Cohorts G, H, K, and L presenting with a single target lesion and absence of any non-target lesion.
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- Consent to provide an archival tumor tissue sample (if available, applicable to all participants)
- Willingness to undergo baseline and on-treatment tumor biopsies for pharmacodynamics (PD) biomarker analysis (biopsies are optional for Cohort A)
- Adequate cardiovascular function as defined in the study protocol
- AEs related to any previous radiotherapy, chemotherapy, or surgical procedure must have resolved to Grade less than or equal to (<=) 1, except alopecia (any grade) and Grade 2 peripheral neuropathy
- Adequate haematological, liver, and renal functions.
- Participants with unilateral pleural effusion (indications other than NSCLC) are eligible if they fulfill both of the following:
- NYHA Class 1
- Forced expiratory volume 1 (FEV1) and forced vital capacity (FVC) >70% of predicted value; participants with lung metastases should present with DLCO >60% of predicted value.
- Participants with Gilbert's syndrome will be eligible for the study
- Participants must have had confirmed diagnosis of recurrent or metastatic squamous cell carcinoma head and neck, or esophageal cancer or metastatic, persistent or recurrent squamous cervical cancer.
Who cannot join
- Symptomatic or untreated central nervous system (CNS) metastases
- History of treated asymptomatic CNS metastases as described in the protocol
- Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for >=2 weeks before enrollment
- Leptomeningeal disease
- An active second malignancy
- Penetrating tumor infiltration
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- Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
- Episode of significant cardiovascular/cerebrovascular acute disease within 6 months before study treatment administration
- History of significant vascular disease (for example, aortic aneurysm, aortic dissection)
- Active or uncontrolled infections
- Human immunodeficiency virus (HIV) or Active Hepatitis A, B, C, D or E infection (HAV/HBV/HCV/HDV/HEV).
- Severe infection within 4 weeks before study treatment administration including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia.
- History of chronic liver disease or evidence of hepatic cirrhosis
- Dementia or altered mental status that would prohibit informed consent
- History of, active or suspicion of autoimmune disease
- History of idiopathic pulmonary fibrosis, pneumonitis (including drug-induced), organizing pneumonia (bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
- Bilateral pleural effusion confirmed by X-ray
- Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that give reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug
- Concurrent therapy with any other investigational drug
- Immunomodulating agents as described in study protocol
- Chronic use of steroids
- Last dose with any cytostatic treatments < 28 days before study treatment administration
- Radiotherapy within the last 4 weeks before start of study treatment administration, with the exception of limited field palliative radiotherapy
- Administration of a live, attenuated vaccine within 4 weeks before Cycle 1 Day 1 or at any time during the study and 5 months after the last dose of atezolizumab
- Major surgery or significant traumatic injury <28 days before study treatment administration (excluding fine needle biopsies) or if wound healing has not completed after surgery or anticipation of the need for major surgery during study treatment
- Known hypersensitivity to any of the components of the simlukafusp alfa drug product or atezolizumab drug product
- Severe dyspnea at rest or requiring supplementary oxygen therapy Locally curative options are available for participant's disease.
Trial locations and contacts
44 sites in 15 countries.
44 sites in 15 countries
Spain8 sites
Hospital del Mar; Servicio de Oncologia
Barcelona, 08003
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona, 08035
Clinica Universidad de Navarra Madrid; Servicio de Oncología
Madrid, 28027
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid, 28034
START Madrid-FJD, Hospital Fundacion Jimenez Diaz
Madrid, 28040
START Madrid. Centro Integral Oncologico Clara Campal; CIOCC
Madrid, 28050
Clinica Universitaria de Navarra
Pamplona, Navarre, 31008
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
Valencia, 46010
Turkey (Türkiye)6 sites
Adana Baskent University Hospital; Medical Oncology
Adana, 01120
Akdeniz University Medical Faculty; Medical Oncology Department
Antalya, 07070
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
Edirne, 22030
Istanbul University Cerrahpa?a-Cerrahpa?a Medical Faculty; Medikal Onkoloji Departmani
Istanbul, 34098
?zmir Medical Park; Onkoloji
Izmir
Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology
Kadiköy, 34722
South Korea5 sites
Seoul National University Bundang Hospital
Seongnam-si, 13620
Severance Hospital, Yonsei University Health System
Seoul, 003-722
Seoul National University Hospital
Seoul, 03080
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 135-710
France4 sites
Institut Bergonie
Bordeaux, 33076
Hopital Timone Adultes; Oncologie Medicale Et Usp
Marseille, 13385
ICM; Medecine B3
Montpellier, 34298
Gustave Roussy Cancer Campus
Villejuif, 94805
United Kingdom4 sites
Barts
London, EC1M6BQ
University College London Hospital
London, N7 9NH
Christie Hospital Nhs Trust; Medical Oncology
Manchester, M2O 4BX
Royal Marsden Hospital; Institute of Cancer Research
Sutton, SM2 5PT
Belgium3 sites
UZ Antwerpen
Edegem, 2650
UZ Gent
Ghent, 9000
UZ Leuven Gasthuisberg
Leuven, 3000
United States2 sites
Cancer Treatment Centers of America
Newnan, Georgia, 30265
University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94158
Poland2 sites
Uniwersyteckie Centrum Kliniczne; Osrodek Badan Wczesnych Faz
Gda?sk, 80-214
Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie; Oddzial Badan Wczesnych Faz
Warsaw, 02-781
Russia2 sites
N.N.Burdenko Main Military Clinical Hospital; Oncology Dept
Moscow, 105229
S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
Saint Petersburg, 197758
Singapore2 sites
National University Hospital; National University Cancer Institute, Singapore (NCIS)
Singapore, 119228
National Cancer Centre; Medical Oncology
Singapore, 169610
Taiwan2 sites
National Cheng Kung Uni Hospital; Dept of Hematology and Oncology
Tainan, 704
National Taiwan Uni Hospital; Dept of Oncology
Taipei, 100
Germany1 site
Universitätsklinikum Essen; Innere Klinik (Tumorforschung)
Essen, 45147
New Zealand1 site
Auckland City Hospital; Clinical Oncology
Auckland, 1023
Switzerland1 site
Hôpitaux Universit. de Genève Médecine Oncologie; Oncologie
Geneva, 1211
About this study
Official title: An Open-Label, Multicenter, Phase II Study to Evaluate the Therapeutic Activity of Simlukafusp Alfa (RO6874281), an Immunocytokine, Consisting of Interleukin-2 Variant (IL-2v) Targeting Fibroblast Activation Protein-Α (FAP), in Combination With Atezolizumab (Anti-PD-L1), Administered Intravenously, in Participants With Advanced and/or Metastatic Solid Tumors
This is an open-label, multicenter, basket trial Phase II study to evaluate the antitumor activity of simlukafusp alfa in combination with atezolizumab in participants with advanced and/or metastatic solid tumors. Currently the focus is on participants with Head and Neck, oesophageal and cervical cancers with confirmed squamous cell carcinoma histology type.
- Being tested
- simlukafusp alfa, Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody, Gemcitabine, Vinorelbine
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simlukafusp alfaDrug
Also called RO6874281
simlukafusp alfa will be administered as per the dosage regimen mentioned in arm descriptions.
Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 AntibodyDrug
Atezolizumab will be administered as per the dosage regimen mentioned in arm descriptions.
GemcitabineDrug
Single-agent treatment administered as per approved protocol.
VinorelbineDrug
Single-agent treatment administered as per approved protocol.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A (Part I) | Experimental | Checkpoint Inhibitor (CPI)-Naïve Participants with non-small-cell lung cancer (NSCLC) who have not received CPI therapy previously will receive simlukafusp alfa intravenous (IV) infusion once in a week (QW) for first 5 doses, and once in 2 weeks (Q2W) for remaining doses up to maximum 36 months. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered in combination Q2W at a dose of 840 mg. Tumor biopsies: collection of fresh tumor biopsies (at baseline and on-treatment) will be optional. Receives: Drug: simlukafusp alfa; Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody |
| Cohort B (Part I) | Experimental | CPI-Experienced Participants (NSCLC) who have received CPI therapy previously will receive simlukafusp alfa intravenous (IV) infusion once in a week (QW) for first 5 doses, and once in 2 weeks (Q2W) for remaining doses up to maximum 36 months. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered in combination Q2W at a dose of 840 mg. Tumor biopsies: 2 mandatory fresh tumor biopsies, one at baseline and one on-treatment, will be collected. Additional on-treatment biopsies will be optional. Receives: Drug: simlukafusp alfa; Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody |
| Cohort C (Part I) | Experimental | This is a mandatory biopsy cohort based on the treatment's safety and preliminary activity analysis to enroll CPI-Naive Participants. Participants (NSCLC) will receive simlukafusp alfa intravenous (IV) infusion once in a week (QW) for first 5 doses, and once in 2 weeks (Q2W) for remaining doses up to maximum 36 months. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered in combination Q2W at a dose of 840 mg.
Tumor biopsies: 2 mandatory fresh tumor biopsies, one at baseline and one on-treatment, will be collected. Additional on-treatment biopsies will be optional. Receives: Drug: simlukafusp alfa; Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody |
| Cohort D Arm I (Part I) | Experimental | CPI Experienced Participants (NSCLC) who were previously treated with platinum and docetaxel.
Participants will receive simlukafusp alfa intravenous (IV) infusion once in a week (QW) for first 5 doses, and once in 2 weeks (Q2W) for remaining doses up to maximum 36 months. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered in combination Q2W at a dose of 840 mg.
Tumor biopsies: 2 mandatory fresh tumor biopsies, one at baseline and one on-treatment, will be collected. Additional on-treatment biopsies will be optional. Receives: Drug: simlukafusp alfa; Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody |
| Cohort D Arm 2 (Part I) | Experimental | CPI Experienced Participants (NSCLC) who were previously treated with platinum and docetaxel.
Participants will receive simlukafusp alfa intravenous (IV) infusion once in 3 weeks (Q3W) up to maximum 36 months. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered in combination Q3W at a dose of 1200 mg.
Tumor biopsies: 2 mandatory fresh tumor biopsies, one at baseline and one on-treatment, will be collected. Additional on-treatment biopsies will be optional. Receives: Drug: simlukafusp alfa; Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody |
| Cohort D Arm 3 (Part I) | Experimental | CPI Experienced Participants (NSCLC) who were previously treated with platinum and docetaxel will receive a single-agent gemcitabine or vinorelbine as per approved protocol.
Tumor biopsies: 2 mandatory fresh tumor biopsies, one at baseline and one on-treatment, will be collected. Additional on-treatment biopsies will be optional. Receives: Drug: Gemcitabine; Drug: Vinorelbine |
| Cohort E Arm I (Part II) | Experimental | This cohort will enroll participants (NSCLC) with High-Tumor PD-L1 Expression who have not received any prior systemic therapy. Participants will receive simlukafusp alfa intravenous (IV) infusion once in a week (QW) for first 5 doses, and once in 2 weeks (Q2W) for remaining doses up to maximum 36 months. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered in combination Q2W at a dose of 840 mg.
Tumor biopsies: 2 mandatory fresh tumor biopsies, one at baseline and one on-treatment, will be collected. Additional on-treatment biopsies will be optional. Receives: Drug: simlukafusp alfa; Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody |
| Cohort E Arm 2 (Part II) | Experimental | This cohort will enroll participants (NSCLC) with High-Tumor PD-L1 Expression who have not received any prior systemic therapy. Participants will receive simlukafusp alfa IV infusion in combination with atezolizumab Q3W. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered at a dose of 1200 mg.
Tumor biopsies: 2 mandatory fresh tumor biopsies, one at baseline and one on-treatment, will be collected. Additional on-treatment biopsies will be optional. Receives: Drug: simlukafusp alfa; Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody |
| Cohort F (Part I) | Experimental | CPI-experienced, docetaxel naive participants (NSCLC) who experienced disease progression during or following treatment with a platinum - containing regimen. Participants will receive combination of simlukafusp alfa and atezolizumab in a Q3W schedule. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered at a dose of 1200 mg.
Tumor biopsies: one mandatory fresh tumor biopsy will be collected at baseline. Additional on-treatment biopsies will be optional. Receives: Drug: simlukafusp alfa; Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody |
| Cohort G (Part III) | Experimental | CPI-naïve SCC of the head and neck (SCCHN) (20 response-evaluable participants), mandatory biopsies. Participants in cohort G Part III will receive simlukafusp alfa Q3W in combination with atezolizumab Q3W. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered at a dose of 1200 mg. Tumor biopsies: one mandatory fresh tumor biopsy will be collected at baseline. Additional on-treatment biopsies will be optional. Biopsies are not applicable to participants presenting with a single target lesion and absence of any non-target lesion. Receives: Drug: simlukafusp alfa; Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody |
| Cohort H (Part III) | Experimental | Previously treated, CPI-experienced squamous cell carcinoma head and heck cancer (20 response evaluable participants), mandatory biopsies. Participants in cohort H Part III will receive simlukafusp alfa Q3W in combination with atezolizumab Q3W. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered at a dose of 1200 mg. Tumor biopsies: one mandatory fresh tumor biopsy will be collected at baseline. Additional on-treatment biopsies will be optional. Biopsies are not applicable to participants presenting with a single target lesion and absence of any non-target lesion. Receives: Drug: simlukafusp alfa; Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody |
| Cohort I (Part III) | Experimental | Previously treated, CPI-naïve squamous esophageal cancer (20 response evaluable participants), mandatory biopsies. Participants in cohort I Part III will receive simlukafusp alfa Q3W in combination with atezolizumab Q3W. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered at a dose of 1200 mg. Tumor biopsies: one mandatory fresh tumor biopsy will be collected at baseline. Additional on-treatment biopsies will be optional. Receives: Drug: simlukafusp alfa; Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody |
| Cohort J (Part III) | Experimental | Previously treated, CPI-naïve squamous cervical cancer (20 response evaluable participants): mandatory biopsy. Participants in cohort J Part III will receive simlukafusp alfa Q3W in combination with atezolizumab Q3W. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered at a dose of 1200 mg. Tumor biopsies: one mandatory fresh tumor biopsy will be collected at baseline. Additional on-treatment biopsies will be optional. Receives: Drug: simlukafusp alfa; Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody |
| Cohort K (Part III) | Experimental | CPI-naïve SCC of the head and neck (SCCHN) (20 response-evaluable participants), mandatory biopsies. Participants in cohort K Part III will receive simlukafusp alfa QW in combination with atezolizumab Q2W for 4 weeks followed by simlukafusp alfa in combination with atezolizumab Q2W. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered at a dose of 840 mg. Tumor biopsies: one mandatory fresh tumor biopsy will be collected at baseline. Additional on-treatment biopsies will be optional. Biopsies are not applicable to participants presenting with a single target lesion and absence of any non-target lesion. Receives: Drug: simlukafusp alfa; Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody |
| Cohort L (Part III) | Experimental | Previously treated, CPI-experienced squamous cell carcinoma head and neck cancer (20 response evaluable participants), mandatory biopsies. Participants in cohort L Part III will receive simlukafusp alfa QW in combination with atezolizumab Q2W for 4 weeks followed by simlukafusp alfa in combination with atezolizumab Q2W. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered at a dose of 840 mg. Tumor biopsies: one mandatory fresh tumor biopsy will be collected at baseline. Additional on-treatment biopsies will be optional. Biopsies are not applicable to participants presenting with a single target lesion and absence of any non-target lesion. Receives: Drug: simlukafusp alfa; Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody |
| Cohort M (Part III) | Experimental | Esophageal SCC participants will receive simlukafusp alfa QW in combination with atezolizumab Q2W for 4 weeks followed by simlukafusp alfa in combination with atezolizumab Q2W. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered at a dose of 840 mg. Tumor biopsies: one mandatory fresh tumor biopsy will be collected at baseline. Additional on-treatment biopsies will be optional. Receives: Drug: simlukafusp alfa; Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody |
| Cohort N (Part III) | Experimental | Cervical SCC participants will receive simlukafusp alfa QW in combination with atezolizumab Q2W for 4 weeks followed by simlukafusp alfa in combination with atezolizumab Q2W. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered at a dose of 840 mg. Tumor biopsies: one mandatory fresh tumor biopsy will be collected at baseline. Additional on-treatment biopsies will be optional. Receives: Drug: simlukafusp alfa; Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
ORR was defined as the percentage of participants with observed tumor response of complete response (CR), or partial response (PR) determined according to RECIST version 1.1. CR was defined as the disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The percentages of participants are rounded off to the nearest single decimal point.
Measured: Baseline up to disease progression or study treatment discontinuation (up to 38 months)
Secondary outcomes (9)
Percentage of Participants With Disease Control Rate (DCR) Determined According to RECIST Version 1.1
DCR was defined as the percentage of participants with observed tumor response of CR, PR or stable disease (SD) determined according to RECIST version 1.1. CR was defined as the disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline (nadir). The percentages of participants are rounded off to the nearest single decimal point.
Measured: Baseline up to disease progression or study treatment discontinuation (up to 38 months)
Duration of Response (DoR) According to RECIST Version 1.1
DoR was determined for participants who had a best overall response of CR or PR. CR was defined as the disappearance of all target lesions with a reduction in target/non-target pathological lymph nodes to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. DoR was defined as the time from first occurrence of a documented objective response until the time of documented disease progression or death from any cause during treatment, whichever occurs first. Participants that did not have documented progressive disease or death during the study were censored at the day of the last tumor assessment.
Measured: From first occurrence of documented CR or PR up to disease progression or study treatment discontinuation (assessed every 8 weeks after study treatment start for the first year, and every 12 weeks thereafter, up to 38 months)
Progression-Free Survival (PFS) According to RECIST Version 1.1
PFS was defined as the time from study treatment initiation (Cycle 1 Day 1 [1 cycle=14 days for QW/Q2W cohorts; 1 cycle=21 days for Q3W cohorts]) to the first occurrence of documented disease progression (based on Investigator's assessment) or death from any cause during treatment, whichever occurs first. Participants that did not have documented progressive disease or death during the study were censored at the day of the last tumor assessment.
Measured: Study treatment initiation up to disease progression or study treatment discontinuation (up to 38 months)
Overall Survival (OS)
OS was defined as the time from the first dose of study treatment to the time of death from any cause on study. Participants who were still alive at the time of analysis were censored at the last date known alive.
Measured: From first dose of study treatment up to death due to any cause (up to approximately 47 months)
Percentage of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Measured: Baseline up to end of the study (up to approximately 47 months)
Percentage of Participants by Programmed Death-Ligand 1 (PD-L1) Status According to Immunohistochemical Methods
Measured: Baseline
Change From Baseline in Density of Cluster of Differentiation (CD) 8 Positive (CD8+) Cells According to Immunohistochemical Methods
Measured: Baseline up 2 months
Change From Baseline in Density of Cluster of Differentiation 3 Negative (CD3-) Perforin Positive Cells According to Immunohistochemical Methods
Measured: Baseline up to 2 months
Change From Baseline in Density of PD-L1 According to Immunohistochemical Methods
Measured: Baseline up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2017
- Study start19 Feb 2018
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Why it stopped: The Sponsor discontinued the development of Simlukafusp alfa due to portfolio prioritization, not due to any safety, efficacy, or quality issues.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Advanced/Metastatic Head and Neck, Oesophageal and Cervical CancersStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03386721
- Sponsor's protocol ID
- BP40234
- Other IDs
- 2017-003182-94, 2017
- Status last verified
- Feb 2023
- First submitted
- 22 Dec 2017
- Last updated
- 21 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).
Publications
Verlingue L, Italiano A, Prenen H, Guerra Alia EM, Tosi D, Perets R, Lugowska I, Moiseyenko V, Gumus M, Arslan C, Lindsay CR, Deva S, Taus A, Oaknin A, Rottey S, Cicin I, Goksu SS, Smolin A, Rosello-Keranen S, Habigt C, Marbach D, Boetsch C, Dejardin D, Sleiman N, Evers S, Richard M, Ardeshir C, Charo J, Kraxner A, Teichgraber V, Keshelava N, Dziadziuszko R. Phase 2 study of the antitumour activity and safety of simlukafusp alfa (FAP-IL2v) combined with atezolizumab in patients with recurrent and/or metastatic cervical squamous cell carcinoma. EBioMedicine. 2024 Nov;109:105374. doi: 10.1016/j.ebiom.2024.105374. Epub 2024 Oct 11.
PubMed 39395231Prenen H, Deva S, Keam B, Lindsay CR, Lugowska I, Yang JC, Longo F, de Miguel M, Ponz-Sarvise M, Ahn MJ, Gumus M, Champiat S, Italiano A, Salas S, Perets R, Arslan C, Cho BC, Evers S, Boetsch C, Marbach D, Dejardin D, Sleiman N, Ardeshir C, Richard M, Charo J, Kraxner A, Keshelava N, Teichgraber V, Moreno V. Phase II Study to Determine the Antitumor Activity and Safety of Simlukafusp Alfa (FAP-IL2v) Combined with Atezolizumab in Esophageal Cancer. Clin Cancer Res. 2024 Jul 15;30(14):2945-2953. doi: 10.1158/1078-0432.CCR-23-2677.
PubMed 38709220
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, Phase II Study to Evaluate the Therapeutic Activity of Simlukafusp Alfa (RO6874281), an Immunocytokine, Consisting of Interleukin-2 Variant (IL-2v) Targeting Fibroblast Activation Protein-Α (FAP), in Combination With Atezolizumab (Anti-PD-L1), Administered Intravenously, in Participants With Advanced and/or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT03386721
- Acronym / sponsor ID
- BP40234
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The Sponsor discontinued the development of Simlukafusp alfa due to portfolio prioritization, not due to any safety, efficacy, or quality issues.
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 19 Feb 2018 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 29 Dec 2017 (actual)
- Results
- Posted 21 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, multicenter, basket trial Phase II study to evaluate the antitumor activity of simlukafusp alfa in combination with atezolizumab in participants with advanced and/or metastatic solid tumors. Currently the focus is on participants with Head and Neck, oesophageal and cervical cancers with confirmed squamous cell carcinoma histology type.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 17
| Arm | Type | Receives |
|---|---|---|
| Cohort A (Part I) | Experimental | Drug: simlukafusp alfa, Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 AntibodyCheckpoint Inhibitor (CPI)-Naïve Participants with non-small-cell lung cancer (NSCLC) who have not received CPI therapy previously will receive simlukafusp alfa intravenous (IV) infusion once in a week (QW) for first 5 doses, and once in 2 weeks (Q2W) for remaining doses up to maximum 36 months. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered in combination Q2W at a dose of 840 mg. Tumor biopsies: collection of fresh tumor biopsies (at baseline and on-treatment) will be optional. |
| Cohort B (Part I) | Experimental | Drug: simlukafusp alfa, Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 AntibodyCPI-Experienced Participants (NSCLC) who have received CPI therapy previously will receive simlukafusp alfa intravenous (IV) infusion once in a week (QW) for first 5 doses, and once in 2 weeks (Q2W) for remaining doses up to maximum 36 months. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered in combination Q2W at a dose of 840 mg. Tumor biopsies: 2 mandatory fresh tumor biopsies, one at baseline and one on-treatment, will be collected. Additional on-treatment biopsies will be optional. |
| Cohort C (Part I) | Experimental | Drug: simlukafusp alfa, Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 AntibodyThis is a mandatory biopsy cohort based on the treatment's safety and preliminary activity analysis to enroll CPI-Naive Participants. Participants (NSCLC) will receive simlukafusp alfa intravenous (IV) infusion once in a week (QW) for first 5 doses, and once in 2 weeks (Q2W) for remaining doses up to maximum 36 months. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered in combination Q2W at a dose of 840 mg. Tumor biopsies: 2 mandatory fresh tumor biopsies, one at baseline and one on-treatment, will be collected. Additional on-treatment biopsies will be optional. |
| Cohort D Arm I (Part I) | Experimental | Drug: simlukafusp alfa, Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 AntibodyCPI Experienced Participants (NSCLC) who were previously treated with platinum and docetaxel. Participants will receive simlukafusp alfa intravenous (IV) infusion once in a week (QW) for first 5 doses, and once in 2 weeks (Q2W) for remaining doses up to maximum 36 months. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered in combination Q2W at a dose of 840 mg. Tumor biopsies: 2 mandatory fresh tumor biopsies, one at baseline and one on-treatment, will be collected. Additional on-treatment biopsies will be optional. |
| Cohort D Arm 2 (Part I) | Experimental | Drug: simlukafusp alfa, Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 AntibodyCPI Experienced Participants (NSCLC) who were previously treated with platinum and docetaxel. Participants will receive simlukafusp alfa intravenous (IV) infusion once in 3 weeks (Q3W) up to maximum 36 months. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered in combination Q3W at a dose of 1200 mg. Tumor biopsies: 2 mandatory fresh tumor biopsies, one at baseline and one on-treatment, will be collected. Additional on-treatment biopsies will be optional. |
| Cohort D Arm 3 (Part I) | Experimental | Drug: Gemcitabine, Drug: VinorelbineCPI Experienced Participants (NSCLC) who were previously treated with platinum and docetaxel will receive a single-agent gemcitabine or vinorelbine as per approved protocol. Tumor biopsies: 2 mandatory fresh tumor biopsies, one at baseline and one on-treatment, will be collected. Additional on-treatment biopsies will be optional. |
| Cohort E Arm I (Part II) | Experimental | Drug: simlukafusp alfa, Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 AntibodyThis cohort will enroll participants (NSCLC) with High-Tumor PD-L1 Expression who have not received any prior systemic therapy. Participants will receive simlukafusp alfa intravenous (IV) infusion once in a week (QW) for first 5 doses, and once in 2 weeks (Q2W) for remaining doses up to maximum 36 months. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered in combination Q2W at a dose of 840 mg. Tumor biopsies: 2 mandatory fresh tumor biopsies, one at baseline and one on-treatment, will be collected. Additional on-treatment biopsies will be optional. |
| Cohort E Arm 2 (Part II) | Experimental | Drug: simlukafusp alfa, Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 AntibodyThis cohort will enroll participants (NSCLC) with High-Tumor PD-L1 Expression who have not received any prior systemic therapy. Participants will receive simlukafusp alfa IV infusion in combination with atezolizumab Q3W. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered at a dose of 1200 mg. Tumor biopsies: 2 mandatory fresh tumor biopsies, one at baseline and one on-treatment, will be collected. Additional on-treatment biopsies will be optional. |
| Cohort F (Part I) | Experimental | Drug: simlukafusp alfa, Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 AntibodyCPI-experienced, docetaxel naive participants (NSCLC) who experienced disease progression during or following treatment with a platinum - containing regimen. Participants will receive combination of simlukafusp alfa and atezolizumab in a Q3W schedule. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered at a dose of 1200 mg. Tumor biopsies: one mandatory fresh tumor biopsy will be collected at baseline. Additional on-treatment biopsies will be optional. |
| Cohort G (Part III) | Experimental | Drug: simlukafusp alfa, Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 AntibodyCPI-naïve SCC of the head and neck (SCCHN) (20 response-evaluable participants), mandatory biopsies. Participants in cohort G Part III will receive simlukafusp alfa Q3W in combination with atezolizumab Q3W. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered at a dose of 1200 mg. Tumor biopsies: one mandatory fresh tumor biopsy will be collected at baseline. Additional on-treatment biopsies will be optional. Biopsies are not applicable to participants presenting with a single target lesion and absence of any non-target lesion. |
| Cohort H (Part III) | Experimental | Drug: simlukafusp alfa, Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 AntibodyPreviously treated, CPI-experienced squamous cell carcinoma head and heck cancer (20 response evaluable participants), mandatory biopsies. Participants in cohort H Part III will receive simlukafusp alfa Q3W in combination with atezolizumab Q3W. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered at a dose of 1200 mg. Tumor biopsies: one mandatory fresh tumor biopsy will be collected at baseline. Additional on-treatment biopsies will be optional. Biopsies are not applicable to participants presenting with a single target lesion and absence of any non-target lesion. |
| Cohort I (Part III) | Experimental | Drug: simlukafusp alfa, Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 AntibodyPreviously treated, CPI-naïve squamous esophageal cancer (20 response evaluable participants), mandatory biopsies. Participants in cohort I Part III will receive simlukafusp alfa Q3W in combination with atezolizumab Q3W. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered at a dose of 1200 mg. Tumor biopsies: one mandatory fresh tumor biopsy will be collected at baseline. Additional on-treatment biopsies will be optional. |
| Cohort J (Part III) | Experimental | Drug: simlukafusp alfa, Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 AntibodyPreviously treated, CPI-naïve squamous cervical cancer (20 response evaluable participants): mandatory biopsy. Participants in cohort J Part III will receive simlukafusp alfa Q3W in combination with atezolizumab Q3W. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered at a dose of 1200 mg. Tumor biopsies: one mandatory fresh tumor biopsy will be collected at baseline. Additional on-treatment biopsies will be optional. |
| Cohort K (Part III) | Experimental | Drug: simlukafusp alfa, Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 AntibodyCPI-naïve SCC of the head and neck (SCCHN) (20 response-evaluable participants), mandatory biopsies. Participants in cohort K Part III will receive simlukafusp alfa QW in combination with atezolizumab Q2W for 4 weeks followed by simlukafusp alfa in combination with atezolizumab Q2W. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered at a dose of 840 mg. Tumor biopsies: one mandatory fresh tumor biopsy will be collected at baseline. Additional on-treatment biopsies will be optional. Biopsies are not applicable to participants presenting with a single target lesion and absence of any non-target lesion. |
| Cohort L (Part III) | Experimental | Drug: simlukafusp alfa, Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 AntibodyPreviously treated, CPI-experienced squamous cell carcinoma head and neck cancer (20 response evaluable participants), mandatory biopsies. Participants in cohort L Part III will receive simlukafusp alfa QW in combination with atezolizumab Q2W for 4 weeks followed by simlukafusp alfa in combination with atezolizumab Q2W. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered at a dose of 840 mg. Tumor biopsies: one mandatory fresh tumor biopsy will be collected at baseline. Additional on-treatment biopsies will be optional. Biopsies are not applicable to participants presenting with a single target lesion and absence of any non-target lesion. |
| Cohort M (Part III) | Experimental | Drug: simlukafusp alfa, Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 AntibodyEsophageal SCC participants will receive simlukafusp alfa QW in combination with atezolizumab Q2W for 4 weeks followed by simlukafusp alfa in combination with atezolizumab Q2W. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered at a dose of 840 mg. Tumor biopsies: one mandatory fresh tumor biopsy will be collected at baseline. Additional on-treatment biopsies will be optional. |
| Cohort N (Part III) | Experimental | Drug: simlukafusp alfa, Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 AntibodyCervical SCC participants will receive simlukafusp alfa QW in combination with atezolizumab Q2W for 4 weeks followed by simlukafusp alfa in combination with atezolizumab Q2W. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered at a dose of 840 mg. Tumor biopsies: one mandatory fresh tumor biopsy will be collected at baseline. Additional on-treatment biopsies will be optional. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Participants who have progressed on at least one previous regimen of anticancer therapy (chemotherapy, mutation targeted therapy, and/or CPI therapy)
- Measurable disease, as defined by RECIST Version 1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 or Karnofsky Performance Score greater than or equal to (>=) 70
- Life expectancy of >=12 weeks
- Confirmed at least one tumor lesion with location accessible to safely biopsy per clinical judgment of the treating physician.
Key exclusion criteria (27 listed)
- Symptomatic or untreated central nervous system (CNS) metastases
- History of treated asymptomatic CNS metastases as described in the protocol
- Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for >=2 weeks before enrollment
- Leptomeningeal disease
- An active second malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| simlukafusp alfaAlso: RO6874281simlukafusp alfa will be administered as per the dosage regimen mentioned in arm descriptions. | Drug | Cohort A (Part I), Cohort B (Part I), Cohort C (Part I), Cohort D Arm 2 (Part I), Cohort D Arm I (Part I), Cohort E Arm 2 (Part II), Cohort E Arm I (Part II), Cohort F (Part I), Cohort G (Part III), Cohort H (Part III), Cohort I (Part III), Cohort J (Part III), Cohort K (Part III), Cohort L (Part III), Cohort M (Part III), Cohort N (Part III) |
| Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 AntibodyAtezolizumab will be administered as per the dosage regimen mentioned in arm descriptions. | Drug | Cohort A (Part I), Cohort B (Part I), Cohort C (Part I), Cohort D Arm 2 (Part I), Cohort D Arm I (Part I), Cohort E Arm 2 (Part II), Cohort E Arm I (Part II), Cohort F (Part I), Cohort G (Part III), Cohort H (Part III), Cohort I (Part III), Cohort J (Part III), Cohort K (Part III), Cohort L (Part III), Cohort M (Part III), Cohort N (Part III) |
| GemcitabineSingle-agent treatment administered as per approved protocol. | Drug | Cohort D Arm 3 (Part I) |
| VinorelbineSingle-agent treatment administered as per approved protocol. | Drug | Cohort D Arm 3 (Part I) |
Primary outcome
Percentage of Participants With Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Time frame: Baseline up to disease progression or study treatment discontinuation (up to 38 months)
ORR was defined as the percentage of participants with observed tumor response of complete response (CR), or partial response (PR) determined according to RECIST version 1.1. CR was defined as the disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The percentages of participants are rounded off to the nearest single decimal point.
9 secondary outcomes
Percentage of Participants With Disease Control Rate (DCR) Determined According to RECIST Version 1.1
Time frame: Baseline up to disease progression or study treatment discontinuation (up to 38 months)
Duration of Response (DoR) According to RECIST Version 1.1
Time frame: From first occurrence of documented CR or PR up to disease progression or study treatment discontinuation (assessed every 8 weeks after study treatment start for the first year, and every 12 weeks thereafter, up to 38 months)
Progression-Free Survival (PFS) According to RECIST Version 1.1
Time frame: Study treatment initiation up to disease progression or study treatment discontinuation (up to 38 months)
Overall Survival (OS)
Time frame: From first dose of study treatment up to death due to any cause (up to approximately 47 months)
Percentage of Participants With Adverse Events (AEs)
Time frame: Baseline up to end of the study (up to approximately 47 months)
Percentage of Participants by Programmed Death-Ligand 1 (PD-L1) Status According to Immunohistochemical Methods
Time frame: Baseline
Change From Baseline in Density of Cluster of Differentiation (CD) 8 Positive (CD8+) Cells According to Immunohistochemical Methods
Time frame: Baseline up 2 months
Change From Baseline in Density of Cluster of Differentiation 3 Negative (CD3-) Perforin Positive Cells According to Immunohistochemical Methods
Time frame: Baseline up to 2 months
Change From Baseline in Density of PD-L1 According to Immunohistochemical Methods
Time frame: Baseline up to 2 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39395231Verlingue L, Italiano A, Prenen H, Guerra Alia EM, Tosi D, Perets R, Lugowska I, Moiseyenko V, Gumus M, Arslan C, Lindsay CR, Deva S, Taus A, Oaknin A, Rottey S, Cicin I, Goksu SS, Smolin A, Rosello-Keranen S, Habigt C, Marbach D, Boetsch C, Dejardin D, Sleiman N, Evers S, Richard M, Ardeshir C, Charo J, Kraxner A, Teichgraber V, Keshelava N, Dziadziuszko R. Phase 2 study of the antitumour activity and safety of simlukafusp alfa (FAP-IL2v) combined with atezolizumab in patients with recurrent and/or metastatic cervical squamous cell carcinoma. EBioMedicine. 2024 Nov;109:105374. doi: 10.1016/j.ebiom.2024.105374. Epub 2024 Oct 11.
- Derived from this study: PubMed 38709220Prenen H, Deva S, Keam B, Lindsay CR, Lugowska I, Yang JC, Longo F, de Miguel M, Ponz-Sarvise M, Ahn MJ, Gumus M, Champiat S, Italiano A, Salas S, Perets R, Arslan C, Cho BC, Evers S, Boetsch C, Marbach D, Dejardin D, Sleiman N, Ardeshir C, Richard M, Charo J, Kraxner A, Keshelava N, Teichgraber V, Moreno V. Phase II Study to Determine the Antitumor Activity and Safety of Simlukafusp Alfa (FAP-IL2v) Combined with Atezolizumab in Esophageal Cancer. Clin Cancer Res. 2024 Jul 15;30(14):2945-2953. doi: 10.1158/1078-0432.CCR-23-2677.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
44 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing simlukafusp alfa, Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody and Gemcitabine in people with Advanced/Metastatic Head and Neck, Oesophageal and Cervical Cancers, run by Hoffmann-La Roche at 44 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in Spain, Turkey (Türkiye), South Korea, France, United Kingdom and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (time frame: Baseline up to disease progression or study treatment discontinuation (up to 38 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03386721, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.