Advanced Solid TumorPhase 2BoBNCT03767075
A Modular Multi-Basket Trial to Improve Personalized Medicine in Cancer Patients (Basket of Baskets)
A Phase 2 study testing Atezolizumab, Futibatinib and Amivantamab in people with Advanced Solid Tumor, run by Vall d'Hebron Institute of Oncology at 8 sites in 7 countries.
Trial summary
The global objective of this Basket of Basket study is to evaluate the antitumor activity of each matched therapies that will be evaluated through the study in small molecularly selected populations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- Atezolizumab, Futibatinib and Amivantamab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 8 sitesin 7 countries
- Study dates
- 10 Dec 2018to Nov 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Subjects must have histologically or cytologically confirmed malignancy that is metastatic or unresectable, who have progressed to standard therapy, who are receiving a standard anticancer treatment, but no subsequent approved treatment would be available upon progression, who are unable to receive standard therapy, or for whom standard therapy does not exist.
- Patient must have ECOG performance status of 0 or 1.
- Subjects must be 18-year-old or older.
- Subjects must have measurable disease according to RECIST 1.1.
- Subjects must have enough tumour tissue for molecular analysis.
- Subjects providing formalin-fixed paraffin embedded tissue (FFPE) must provide a minimum amount of tissue ranging from 28 to 36 slides depending on the sample tumour cellularity. If there is not enough archival tissue to meet this criterion, the patient must undergo a tumour biopsy.
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- Subjects providing fresh frozen tissue must provide 5 core biopsies or equivalent.
- Fresh frozen tissue must be preferentially collected from a tumour biopsy; hence, subjects must have disease amenable to be biopsied. Otherwise, the patient should have fresh frozen tumour tissue stored in a biobank or biorepository.
- Efforts will be made to provide fresh frozen tissue in at least one quarter of the participating subjects. The proportion of subjects that might provide fresh frozen tissue might change based on the results from the molecular analysis.
- Since some of the tests are performed in FFPE tissue, subjects providing fresh frozen tissue from a recent biopsy will have part of the sample processed in FFPE as per Laboratory manual.
- Subjects must have adequate haematological, renal, and hepatic function.
- For subjects requiring a tumour biopsy: subjects must have adequate coagulation function.
- Subjects must be willing to participate in a clinical trial with a matched therapy according to the molecular profile of his/her tumour.
- Subjects must have metastatic or unresectable malignant tumour, histologically or cytological confirmed and progressing to current therapy. Tumours must be refractory to standard therapy or for which standard therapy does not exist, or subjects may be unable to receive standard therapy.
- Patient must have ECOG performance status of 0 or 1.
- Subjects must be 18-year-old or older.
- Subjects must have measurable disease according to RECIST 1.1.
- Subjects must be willing to participate in a clinical trial with a matched therapy according to the molecular profile of his/her tumour.
- Tumours must harbour the following alterations.
- Subjects must have adequate hematological, renal, and hepatic function.
- For subjects requiring a tumour biopsy: subjects must have adequate coagulation function.
- A woman of childbearing potential must have a negative serum pregnancy test within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy test during the study.
- A woman must be either of the following:
- Not of childbearing potential.
- Of childbearing potential and practicing true abstinence during the entire period of the study, including up to 6 months after the last dose of study treatment is given.
- Of childbearing potential and practicing 2 methods of contraception, including 1 highly effective user independent method and a second method. Participant must agree to continue contraception throughout the study and through 6 months after the last dose of study treatment.
- A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 6 months after receiving the last dose of study treatment.
- A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 6 months after receiving the last dose of study treatment.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Subjects with leptomeningeal disease should be excluded from this clinical trial.
- Subjects with known unstable brain metastases should be excluded from this clinical trial. Exception: Subjects who have undergone surgery and/or radiotherapy and in which brain metastases remain stable or decrease in size for six months after having completed therapy.
- Subjects with spinal cord compression not definitively treated with surgery and/or radiation.
- Subjects with uncontrolled intercurrent illness including, but not limited to, active infection, symptomatic congestive heart failure, LVEF < 50%, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Subjects with inability to swallow tablets or capsules.
- Subjects with known HIV, hepatitis B or hepatitis C infection.
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- Subjects with known history of malabsorption.
- Eligibilty Criteria (PART B - iBASKET)
- Pregnant or breastfeeding women. Females of childbearing potential must have a negative serum pregnancy test within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy test during the study.
- Any approved anticancer therapy, including chemotherapy, hormonal therapy or radiotherapy, within 3 weeks prior to initiation of study treatment; however, the following are allowed:
- Hormone-replacement therapy or oral contraceptives.
- Somatostatin analogues for the treatment of symptoms related with neuroendocrine tumours.
- Gonadotropin-releasing hormone agonists or antiandrogens for prostate cancer.
- Palliative radiotherapy for bone metastases > 2 weeks prior to Cycle 1, Day 1.
- Treatment with an investigational agent within 3 weeks prior to Cycle 1, Day 1 (or within five half-lives of the investigational product, whichever is longer).
- Patients with recent major surgery or invasive procedure within 15 days before the fist dose of the study drug.
- Participant has unstable symptomatic brain metastases. A participant with asymptomatic or previously treated and stable brain metastases may participate in this study.
- Participants who have received definitive radiation or surgical treatment for symptomatic or unstable brain metastases and have been clinically stable and asymptomatic for at least 2 weeks before enrolment are eligible, provided they have been either off corticosteroid treatment or are stable or tapering doses below 4 mg of dexamethasone.
- Patients with meningeal or leptomeningeal carcinomatosis.
- Uncontrolled intercurrent illness including, but not limited to, active infection, cardiovascular disease, or psychiatric illness/social situations that would limit compliance with study requirements.
- Positive hepatitis B (hepatitis B virus [HBV]) surface antigen (HBsAg). Note: Subjects with a prior history of HBV demonstrated by positive hepatitis B core antibody are eligible if they have at Screening 1) a negative HBsAg and 2) an HBV DNA (viral load) below the lower limit of quantification, per local testing.
- Positive hepatitis C antibody (anti-HCV). Note: Subjects with a prior history of HCV, who have completed antiviral treatment and have subsequently documented HCV RNA below the lower limit of quantification per local testing are eligible.
- Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class III or greater), myocardial infarction within 3 months prior to Cycle 1, Day 1, unstable angina or unstable clinically meaningful arrhythmias.
- Another primary malignancy other than disease under study within 2 years prior to Cycle 1 Day 1, unless consider at low risk of relapse at Investigator discretion.
- Contraindications included in the product information of the drugs used in the study.
- Other protocol specified criteria for each module. The study center will determine if criteria for participation are met.
Trial locations and contacts
8 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 7 countries
Germany2 sites, 2 recruiting
- Recruiting
Universitätsklinikum Dresden
Dresden, 01307
Christoph Johannes Heining, MD, Christoph.Heining@uniklinikum-dresden.de
- Recruiting
Deutsches Krebsforschungszentrum (NCT/DKFZ)
Heidelberg, Baden-Wurttemberg, 69120
Richard Schlenk, MD, richard.schlenk@nct-heidelberg.de
France1 site, 1 recruiting
- Recruiting
Institut Gustave Roussy
Villejuif, 94800
Yohann Loriot, Yohann.LORIOT@gustaveroussy.fr
Italy1 site, 1 recruiting
- Recruiting
Instituto Nazionale dei Tumori di Milano
Milan, 20133
Filippo de Braud, MD, filippo.debraud@istitutotumori.mi.it
Netherlands1 site, 1 recruiting
- Recruiting
Nederland Kanker Instituut (NKI)
Amsterdam, 1066
Frans Opdam, MD, f.opdam@nki.nl
Spain1 site, 1 recruiting
- Recruiting
Hospital Vall d'Hebron
Barcelona, 08035
Irene Braña, MD, ibrana@vhio.net
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital Solna
Stockholm, 17176
Luigi de Petris, MD, Luigi.depetris@ki.se
United Kingdom1 site, 1 recruiting
- Recruiting
Cancer Research UK Cambridge Centre
Cambridge, CB2 0QQ
Richard Baird, MD, richard.baird@medschl.cam.ac.uk
About this study
Official title: Basket of Baskets: A Modular, Open-label, Phase II, Multicentre Study To Evaluate Targeted Agents in Molecularly Selected Populations With Advanced Solid Tumours
The global objective of this Basket of Basket study is to evaluate the antitumor activity of each matched therapies that will be evaluated through the study in small molecularly selected populations.
The objective of module 1 wil be to determine the overall response rate (ORR) at 12 weeks by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of atezolizumab in each of the arms of the module. All patients in genomically selected populations will receive atezolizumab 1200 mg IV every 3 weeks.
Read more
The objective of module 2 wil be to determine the overall response rate (ORR) at 16 weeks by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of futibatinib in each of the arms of the module. All patients in genomically selected populations will receive will receive futibatinib, 20 mg, once daily (QD) in 28-day cycles.
The objective of module 3 wil be to determine the overall response rate (ORR) at 12 weeks by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of amivantamab in each of the arms of the module. All patients in genomically selected populations will receive amivantamab 1050 mg intravenously (IV) for body weight < 80 kg and 1400 mg for body weight >= 80 kg mg once weekly in Cycle 1 (with a split dose on Days 1-2) and then every 2 weeks in subsequent cycles (28-day cycles).
Read the detailed description
Basket studies are a new sort of clinical studies to identify patients with the same kind of mutations and treat them with the same drug, irrespective of their specific cancer type. In basket studies, depending on the mutation types, patients are classified into "baskets". Targeted therapies that block that mutation are then identified and assigned to baskets where patients are treated accordingly.
This protocol has two parts: part A (iPROFILER), which includes the common procedures for tumor molecular profiling and treatment recommendation, and part B (iBASKET), which corresponds to the therapeutic portion.
The purpose of part A (iPROFILER) of this study is to test participants' tumour tissue in order to identify whether their tumour has certain mutations in cancer-related genes. It is known that gene mutations of tumours contribute to their origin and growth and determine whether the tumour will respond to particular cancer drugs. This test will provide information about potential targeted therapies that specifically attack those gene mutations. The purpose of part B (iBASKET) of this study is to offer participants a personalised anti-cancer treatment based on the gene mutations that are found in their tumour.
Participants taking part in module 1 of part B (iBASKET) will receive atezolizumab 1200 mg IV every 3 weeks, following the analysis of their tumour in part A (iPROFILER). Participants will be able to take atezolizumab for as long as their tumour doesn't grow and for as long as they don't have any side-effects which prevent them from continuing treatment. Module 1 will have a 2-year recruitment period. The aim of the study is to determine which genomically selected populations respond effectively to the targeted treatment, atezolizumab. Approximately 1000 participants will be enrolled into part A (iPROFILER), with approximately 120 participants being recruited into module 1 of part B (iBASKET).
Participants taking part in module 2 of part B (iBASKET) will receive will receive futibatinib, 20 mg, once daily (QD) in 28-day cycles, following the analysis of their tumour in part A (iPROFILER). Participants will be able to take futibatinib for as long as their tumour doesn't grow and for as long as they don't have any side-effects which prevent them from continuing treatment. Module 2 will have a 2-year recruitment period. The aim of the study is to determine which genomically selected populations respond effectively to the targeted treatment, futibatinib. Approximately 1000 participants will be enrolled into part A (iPROFILER), with approximately 80 participants being recruited into module 2 of part B (iBASKET).
Participants taking part in module 3 of part B (iBASKET) will receive amivantamab 1050 mg IV for body weight < 80 kg and 1400 mg for body weight >= 80 kg mg once weekly in Cycle 1 (with a split dose on Days 1-2) and then every 2 weeks in subsequent cycles (28-day cycles), following the analysis of their tumour in part A (iPROFILER). Participants will be able to take amivantamab for as long as their tumour doesn't grow and for as long as they don't have any side-effects which prevent them from continuing treatment. Module 3 will have a 2.5-year recruitment period. The aim of the study is to determine which genomically selected populations respond effectively to the targeted treatment, amivantamab. Approximately 1725 participants will be enrolled into part A (iPROFILER), with approximately 69 participants being recruited into module 3 of part B (iBASKET).
- Conditions
- Advanced Solid Tumor
- Being tested
- Atezolizumab, Futibatinib, Amivantamab
- Keywords
- Advanced Solid Tumor, Cancer, Atezolizumab, Immunotherapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtezolizumabDrug
1200 mg, administered IV, once every 3 weeks
FutibatinibDrug
Also called TAS-120
20 mg administered orally, once daily (QD) continuously in 28-day cycles.
AmivantamabDrug
Also called JNJ-372
1050 mg administered IV for body weight < 80 kg and 1400 mg for body weight >= 80 kg mg once weekly in Cycle 1 (with a split dose on Days 1-2) and then every 2 weeks in subsequent cycles (28-day cycles)
| Study group | Role | What they receive |
|---|---|---|
| Module 1 - Atezolizumab | Experimental | Genomically selected populations will all receive the same drug
* Arm 1A: BRCA1 or BRCA2 mutations
* Arm 1B: MLH1, MSH2, MSH6, or PMS2 mutations
* Arm 1C: tumors with POLE mutation, POLD1 mutation
* Arm 1D: hypermutated tumors
* Arm 1E: tumors with other mutations in DNA-repair genes
* Arm 1F: tumors with amplified PDL1
* Arm 1G: tumours with CDK12 mutations
Subjects will be recruited and allocated to arms according to their biomarker profile. It is assumed that 1000 subjects will need to be screened in part A in order to enroll 120 patients in part B of module 1. Receives: Drug: Atezolizumab |
| Module 2 - Futibatinib | Experimental | Genomically selected populations will all receive the same drug
* Arm 2A: Known pathogenic FGFR1-3 mutations
* Arm 2B: Variants of unknown significance in FGFR1-3 with functional relevance or pathogenic FGFR4 mutations.
* Arm 2C: Highly amplified FGFR1-3 with high FGFR1-3 mRNA (with the exception of gastric and breast cancer)
* Arm 2D: Highly amplifiedFGFR1-3 without high FGFR1-3 mRNA (with the exception of gastric and breast cancer)
Subjects will be recruited and allocated to arms according to their biomarker profile. It is assumed that 2000 subjects will need to be screened in part A in order to enroll 80 patients in part B of module 2. Receives: Drug: Futibatinib |
| Module 3 - Amivantamab | Experimental | Genomically selected populations will all receive the same drug
* Arm 3A: kinase domain mutations/ MET fusion-genes (including intragene exon skipping MET-MET fusions)
* Arm 3B: MET copy number gain (equivalent CNG ≥6) (exception: colorectal cancer)
* Arm 3C: EGFR mutations (exception: primary lung malignancies)
Subjects will be recruited and allocated to arms according to their biomarker profile. It is assumed that 1725 subjects will need to be screened in part A in order to enroll 69 patients in part B of module 3. Receives: Drug: Amivantamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Proportion of patients with a partial response [PR] or complete response [CR] per RECIST v1.1.
Measured: From the first dose date of study treatment to first CR or PR, whichever came earlier, up to 12 weeks (Module 1 & 3) and 16 weeks (Module 2)
Secondary outcomes (5)
Progression free survival (PFS by RECIST 1.1)
Time from the first dose date of study treatment to the date of investigator-determined objective progression (according to RECIST 1.1) or death from any cause, whichever occurs first.
Measured: From initiation of treatment to objective progression or death from any cause, whichever occurs first, up to two years
Overall Survival
Time from beginning treatment to the time of death from any cause.
Measured: From initiation of treatment to death from any cause, up to two years
Duration of response
Time from documentation of the first CR or PR to the time of first documented evidence of progressive disease (or relapse for subjects who experience CR during the study) or death.
Measured: From documentation of the first CR or PR to the time of first documented evidence of progressive disease (or relapse for subjects who experience CR during the study) or death (up to apprixmatelly 6 months).
Health-related quality of life (HRQoL)
Assessed with the European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30)
Measured: Baseline up to data cut-off, up to two years.
Incidence and severity of adverse events
Type, incidence, severity, timing, seriousness, and relatedness of adverse events and laboratory abnormalities, graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
Measured: From initiation of treatment to 30 days (all adverse events), and 90 days (all SAEs and AESIs), then any SAE considered treatment-related.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start10 Dec 2018
- Primary completionMay 2025 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- 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
- Single group
- Model description
- * Part A includes a molecular profiling program for subjects with advanced solid tumors (iPROFILER) and a molecular tumor board to select the most appropriate treatment based on the molecular alterations found in the iPROFILER. * Part B includes iBASKET, a modular investigator initiated basket study for subjects with selected molecular alterations.
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vall d'Hebron Institute of Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG, IQVIA Pty Ltd, Taisho Pharmaceutical Co., Ltd., Janssen, LP
- Responsible party
- Sponsor
- Investigators
- Jordi Rodon, MD, Study chair, MD Anderson
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03767075
- Sponsor's protocol ID
- VHIO17002
- Other IDs
- 2017-005108-89, 2017
- Acronym
- BoB
- Status last verified
- Apr 2024
- First submitted
- 14 Nov 2018
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Basket of Baskets: A Modular, Open-label, Phase II, Multicentre Study To Evaluate Targeted Agents in Molecularly Selected Populations With Advanced Solid Tumours
- ClinicalTrials.gov ID
- NCT03767075
- Acronym / sponsor ID
- BoB / VHIO17002
- Conditions
- Advanced Solid Tumor
- Keywords
- Advanced Solid Tumor, Cancer, Atezolizumab, Immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Vall d'Hebron Institute of OncologyUniversity, hospital or other
- Collaborators
- Roche Pharma AG, IQVIA Pty Ltd, Taisho Pharmaceutical Co., Ltd., Janssen, LP
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 6 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The global objective of this Basket of Basket study is to evaluate the antitumor activity of each matched therapies that will be evaluated through the study in small molecularly selected populations.
The objective of module 1 wil be to determine the overall response rate (ORR) at 12 weeks by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of atezolizumab in each of the arms of the module. All patients in genomically selected populations will receive atezolizumab 1200 mg IV every 3 weeks.
The objective of module 2 wil be to determine the overall response rate (ORR) at 16 weeks by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of futibatinib in each of the arms of the module. All patients in genomically selected populations will receive will receive futibatinib, 20 mg, once daily (QD) in 28-day cycles.
The objective of module 3 wil be to determine the overall response rate (ORR) at 12 weeks by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of amivantamab in each of the arms of the module. All patients in genomically selected populations will receive amivantamab 1050 mg intravenously (IV) for body weight < 80 kg and 1400 mg for body weight >= 80 kg mg once weekly in Cycle 1 (with a split dose on Days 1-2) and then every 2 weeks in subsequent cycles (28-day cycles).
Detailed description
Basket studies are a new sort of clinical studies to identify patients with the same kind of mutations and treat them with the same drug, irrespective of their specific cancer type. In basket studies, depending on the mutation types, patients are classified into "baskets". Targeted therapies that block that mutation are then identified and assigned to baskets where patients are treated accordingly.
This protocol has two parts: part A (iPROFILER), which includes the common procedures for tumor molecular profiling and treatment recommendation, and part B (iBASKET), which corresponds to the therapeutic portion.
The purpose of part A (iPROFILER) of this study is to test participants' tumour tissue in order to identify whether their tumour has certain mutations in cancer-related genes. It is known that gene mutations of tumours contribute to their origin and growth and determine whether the tumour will respond to particular cancer drugs. This test will provide information about potential targeted therapies that specifically attack those gene mutations. The purpose of part B (iBASKET) of this study is to offer participants a personalised anti-cancer treatment based on the gene mutations that are found in their tumour.
Participants taking part in module 1 of part B (iBASKET) will receive atezolizumab 1200 mg IV every 3 weeks, following the analysis of their tumour in part A (iPROFILER). Participants will be able to take atezolizumab for as long as their tumour doesn't grow and for as long as they don't have any side-effects which prevent them from continuing treatment. Module 1 will have a 2-year recruitment period. The aim of the study is to determine which genomically selected populations respond effectively to the targeted treatment, atezolizumab. Approximately 1000 participants will be enrolled into part A (iPROFILER), with approximately 120 participants being recruited into module 1 of part B (iBASKET).
Participants taking part in module 2 of part B (iBASKET) will receive will receive futibatinib, 20 mg, once daily (QD) in 28-day cycles, following the analysis of their tumour in part A (iPROFILER). Participants will be able to take futibatinib for as long as their tumour doesn't grow and for as long as they don't have any side-effects which prevent them from continuing treatment. Module 2 will have a 2-year recruitment period. The aim of the study is to determine which genomically selected populations respond effectively to the targeted treatment, futibatinib. Approximately 1000 participants will be enrolled into part A (iPROFILER), with approximately 80 participants being recruited into module 2 of part B (iBASKET).
Participants taking part in module 3 of part B (iBASKET) will receive amivantamab 1050 mg IV for body weight < 80 kg and 1400 mg for body weight >= 80 kg mg once weekly in Cycle 1 (with a split dose on Days 1-2) and then every 2 weeks in subsequent cycles (28-day cycles), following the analysis of their tumour in part A (iPROFILER). Participants will be able to take amivantamab for as long as their tumour doesn't grow and for as long as they don't have any side-effects which prevent them from continuing treatment. Module 3 will have a 2.5-year recruitment period. The aim of the study is to determine which genomically selected populations respond effectively to the targeted treatment, amivantamab. Approximately 1725 participants will be enrolled into part A (iPROFILER), with approximately 69 participants being recruited into module 3 of part B (iBASKET).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- * Part A includes a molecular profiling program for subjects with advanced solid tumors (iPROFILER) and a molecular tumor board to select the most appropriate treatment based on the molecular alterations found in the iPROFILER. * Part B includes iBASKET, a modular investigator initiated basket study for subjects with selected molecular alterations.
| Arm | Type | Receives |
|---|---|---|
| Module 1 - Atezolizumab | Experimental | Drug: AtezolizumabGenomically selected populations will all receive the same drug * Arm 1A: BRCA1 or BRCA2 mutations * Arm 1B: MLH1, MSH2, MSH6, or PMS2 mutations * Arm 1C: tumors with POLE mutation, POLD1 mutation * Arm 1D: hypermutated tumors * Arm 1E: tumors with other mutations in DNA-repair genes * Arm 1F: tumors with amplified PDL1 * Arm 1G: tumours with CDK12 mutations Subjects will be recruited and allocated to arms according to their biomarker profile. It is assumed that 1000 subjects will need to be screened in part A in order to enroll 120 patients in part B of module 1. |
| Module 2 - Futibatinib | Experimental | Drug: FutibatinibGenomically selected populations will all receive the same drug * Arm 2A: Known pathogenic FGFR1-3 mutations * Arm 2B: Variants of unknown significance in FGFR1-3 with functional relevance or pathogenic FGFR4 mutations. * Arm 2C: Highly amplified FGFR1-3 with high FGFR1-3 mRNA (with the exception of gastric and breast cancer) * Arm 2D: Highly amplifiedFGFR1-3 without high FGFR1-3 mRNA (with the exception of gastric and breast cancer) Subjects will be recruited and allocated to arms according to their biomarker profile. It is assumed that 2000 subjects will need to be screened in part A in order to enroll 80 patients in part B of module 2. |
| Module 3 - Amivantamab | Experimental | Drug: AmivantamabGenomically selected populations will all receive the same drug * Arm 3A: kinase domain mutations/ MET fusion-genes (including intragene exon skipping MET-MET fusions) * Arm 3B: MET copy number gain (equivalent CNG ≥6) (exception: colorectal cancer) * Arm 3C: EGFR mutations (exception: primary lung malignancies) Subjects will be recruited and allocated to arms according to their biomarker profile. It is assumed that 1725 subjects will need to be screened in part A in order to enroll 69 patients in part B of module 3. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Subjects must have histologically or cytologically confirmed malignancy that is metastatic or unresectable, who have progressed to standard therapy, who are receiving a standard anticancer treatment, but no subsequent approved treatment would be available upon progression, who are unable to receive standard therapy, or for whom standard therapy does not exist.
- Patient must have ECOG performance status of 0 or 1.
- Subjects must be 18-year-old or older.
- Subjects must have measurable disease according to RECIST 1.1.
- Subjects must have enough tumour tissue for molecular analysis.
Key exclusion criteria (26 listed)
- Subjects with leptomeningeal disease should be excluded from this clinical trial.
- Subjects with known unstable brain metastases should be excluded from this clinical trial. Exception: Subjects who have undergone surgery and/or radiotherapy and in which brain metastases remain stable or decrease in size for six months after having completed therapy.
- Subjects with spinal cord compression not definitively treated with surgery and/or radiation.
- Subjects with uncontrolled intercurrent illness including, but not limited to, active infection, symptomatic congestive heart failure, LVEF < 50%, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Subjects with inability to swallow tablets or capsules.
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 |
|---|---|---|
| Atezolizumab1200 mg, administered IV, once every 3 weeks | Drug | Module 1 - Atezolizumab |
| FutibatinibAlso: TAS-12020 mg administered orally, once daily (QD) continuously in 28-day cycles. | Drug | Module 2 - Futibatinib |
| AmivantamabAlso: JNJ-3721050 mg administered IV for body weight < 80 kg and 1400 mg for body weight >= 80 kg mg once weekly in Cycle 1 (with a split dose on Days 1-2) and then every 2 weeks in subsequent cycles (28-day cycles) | Drug | Module 3 - Amivantamab |
Primary outcome
Overall response rate
Time frame: From the first dose date of study treatment to first CR or PR, whichever came earlier, up to 12 weeks (Module 1 & 3) and 16 weeks (Module 2)
Proportion of patients with a partial response [PR] or complete response [CR] per RECIST v1.1.
5 secondary outcomes
Progression free survival (PFS by RECIST 1.1)
Time frame: From initiation of treatment to objective progression or death from any cause, whichever occurs first, up to two years
Overall Survival
Time frame: From initiation of treatment to death from any cause, up to two years
Duration of response
Time frame: From documentation of the first CR or PR to the time of first documented evidence of progressive disease (or relapse for subjects who experience CR during the study) or death (up to apprixmatelly 6 months).
Health-related quality of life (HRQoL)
Time frame: Baseline up to data cut-off, up to two years.
Incidence and severity of adverse events
Time frame: From initiation of treatment to 30 days (all adverse events), and 90 days (all SAEs and AESIs), then any SAE considered treatment-related.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
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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.
Jordi Rodon, MD study chair
MD Anderson
8 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atezolizumab, Futibatinib and Amivantamab in people with Advanced Solid Tumor, run by Vall d'Hebron Institute of Oncology at 8 sites in 7 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 29 inclusion and 26 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: looking for participants now, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, France, Italy, Netherlands, Spain and 2 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marta Carboneras (+34 686 187 838, mcarboneras@vhio.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (time frame: From the first dose date of study treatment to first CR or PR, whichever came earlier, up to 12 weeks (Module 1 & 3) and 16 weeks (Module 2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Apr 2024.