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AzTrials

Solid TumorsPhase 1NCT02304393

A Study of Selicrelumab (RO7009789) in Combination With Atezolizumab in Participants With Locally Advanced and/or Metastatic Solid Tumors

A Phase 1 study testing Atezolizumab and Selicrelumab in people with Solid Tumors, run by Hoffmann-La Roche at 11 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an open-label, multicenter study designed to assess the safety, pharmacokinetics, pharmacodynamics and activity of Selicrelumab administered in combination with Atezolizumab (ATZ) in participants with metastatic or locally advanced solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumors
What is being tested?
Atezolizumab and Selicrelumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
11 sitesin 6 countries
Study dates
12 Dec 2014to 7 Nov 2019
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Histologically confirmed diagnosis of locally advanced and/or metastatic solid tumors, which are not amenable to standard therapy
  • Part I: histologically confirmed diagnosis of advanced/metastatic small and large bowel carcinomas (small bowel and CRC), CPI-experienced non-small cell lung cancer (NSCLC) and head and neck squamous cell carcinoma (HNSCC)
  • Part II: CPI-experienced NSCLC patients must have experienced documented disease progression on or after PD-L1 or PD-1 inhibitor therapy (investigational or approved): screening tumor assessment should confirm prior progression
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy greater than or equal to (>/=) 16 weeks
  • Adequate hematologic and end organ function
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  • Measurable disease per RECIST Version 1.1
  • Ability to comply with the protocol requirements
  • Female participants of childbearing potential must have a negative pregnancy test (urine/serum) within seven days prior to the first study drug administration
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of less than (<) 1% per year during the treatment period and for at least 5 months after the last dose of study treatment
  • For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm during the treatment period and for at least 28 days after the last dose of study treatment

Who cannot join

  • If one of the following laboratory results obtained within 14 days prior to the first study treatment (Cycle 1 Day 1) are: soluble interleukin 2 receptor (sCD25) greater than (>) 2 × upper limit of normal (ULN); Serum ferritin >1000 nanograms per milliliter (ng/mL)
  • Any approved anti-cancer therapy that includes chemotherapy, hormonal therapy, or radiotherapy within 2 weeks prior to the first dose of study treatment; the following is, however, allowed: Palliative radiotherapy for bone metastases less than or equal to (</=) 2 weeks prior to Cycle 1 Day 1
  • Adverse events from prior anti-cancer therapy that have not resolved to Grade </= 1 except for any grade alopecia and </= Grade 2 peripheral neuropathy
  • Bisphosphonate therapy for symptomatic hypercalcemia. Use of bisphosphonate therapy for other reasons (example: bone metastasis or osteoporosis) is allowed
  • Uncontrolled pleural effusion, pericardial effusion, or ascites that require recurrent drainage procedures (one monthly or more frequently). Participants with indwelling catheters are allowed
  • Known clinically significant liver disease which includes active viral, alcoholic, or other hepatitis, cirrhosis, fatty liver, and inherited liver disease
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  • History (within the previous year) of congestive heart failure, stroke, arrhythmia, or myocardial infarction
  • History of peripheral venous thrombosis or thromboembolic event (within 12 months prior to Cycle 1 Day 1)
  • Significant cardio- or cerebrovascular disease within 6 months prior to Cycle 1 Day 1
  • Known hereditary or acquired coagulopathies
  • Clinically meaningful proteinuria
  • Requiring dialysis (peritoneal or hemodialysis)
  • Known primary central nervous system (CNS) malignancy or symptomatic or untreated CNS metastases: participants with asymptomatic-treated CNS metastases may be enrolled after consultation with the Medical Monitor, provided they meet the following criteria:
  • Radiographic demonstration of improvement upon completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study
  • No stereotactic radiation or whole-brain radiation within 28 days prior to Cycle 1 Day 1
  • Pregnancy, lactation, or breastfeeding
  • Allergy or hypersensitivity to components of the RO7009789 formulation or to components of atezolizumab formulation
  • History of autoimmune diseases (participants with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible; participants with controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible for this study)
  • History of idiopathic pulmonary fibrosis, pneumonitis (excluding infectious disease-induced), organizing pneumonia, or evidence of active pneumonitis
  • History of radiation pneumonitis in the radiation field (fibrosis) is permitted
  • Participants with human immunodeficiency virus (HIV) infection, active hepatitis B (chronic or acute), or hepatitis C infection
  • Active tuberculosis
  • Severe infections within 4 weeks prior to Cycle 1 Day 1
  • Signs or symptoms of infection within 2 weeks prior to Cycle 1 Day 1
  • Received oral or IV antibiotics within 2 weeks prior to Cycle 1 Day 1
  • Major surgical procedure within 28 days prior to Cycle 1 Day 1 or anticipation of need for a major surgical procedure during the course of the study
  • Administration of a live, attenuated vaccine within 4 weeks before Cycle 1 Day 1 or anticipation that such a live attenuated vaccine will be required during the study
  • Malignancies other than disease under study within 3 years prior to Cycle 1 Day 1 with the exception of those with a negligible risk of metastasis or death and with expected curative outcome
  • Previous treatment with any other compound that targets cluster of differentiation 40 (CD40) (like Chi Lob 7/4 and ADC1013)
  • Treatment with systemic immunostimulatory agents (including but not limited to interferon (IFN)-alpha, Interleukin-2 (IL-2) within 4 weeks or 5 times the half-life of the drug, whichever is shorter, prior to Cycle 1 Day 1
  • Treatment with investigational agent within 4 weeks prior to Cycle 1 Day 1 (or within 5 times the half-life of the investigational product, whichever is longer)
  • Concomitant treatment with anticoagulants (example: coumadin, heparin) except low dose molecular weight heparin for prophylactic purposes and direct factor Xa inhibitors
  • Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor (TNF) agent within 2 weeks prior to Cycle 1 Day 1
  • Participants who have received acute, low-dose, systemic immunosuppressant medications (example: a one-time dose of dexamethasone for nausea) may be enrolled in the study after discussion with and approval by the Medical Monitor
  • The use of corticosteroids as premedication in case of dye allergy previous to computed tomography (CT) scan is allowed
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
  • Participants with prior allogeneic bone marrow transplantation or prior solid organ transplantation
  • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participants at high risk from treatment complications

Trial locations and contacts

11 sites in 6 countries.

11 sites in 6 countries

France3 sites

  • Aphm; Cpcet

    Marseille, 13385

  • Hopital Saint Louis, Service D Oncologie Medicale

    Paris, 75475

  • Institut Gustave Roussy; Sitep

    Villejuif, 94805

Other trials in France

Canada2 sites

  • Jewish General Hospital / McGill University

    Montreal, Quebec, H3T 1E2

  • University Health Network; Princess Margaret Hospital; Medical Oncology Dept

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Netherlands2 sites

  • Antoni van Leeuwenhoek Ziekenhuis

    Amsterdam, 1066 CX

  • Erasmus Medisch Centrum Rotterdam; Lokatie Daniel den Hoed

    Rotterdam, 3015 GD

Other trials in Netherlands

Spain2 sites

  • Hospital Univ Vall d'Hebron; Servicio de Oncologia

    Barcelona, 08035

  • START Madrid. Centro Integral Oncologico Clara Campal; CIOCC

    Madrid, 28050

Other trials in Spain

United States1 site

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

Denmark1 site

  • Rigshospitalet; Onkologisk Klinik

    København Ø, 2100

Other trials in Denmark

About this study

Official title: An Open-Label, Multicenter, Dose-Escalation Phase IB Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Therapeutic Activity of Selicrelumab (CD40 Agonist) in Combination With Atezolizumab (Anti PD-L1) in Patients With Locally Advanced and/or Metastatic Solid Tumors

This is an open-label, multicenter study designed to assess the safety, pharmacokinetics, pharmacodynamics and activity of Selicrelumab administered in combination with Atezolizumab (ATZ) in participants with metastatic or locally advanced solid tumors. The study will be conducted in two Parts (I and II), with Part I divided into Parts IA and IB. All participants will be followed up for survival until death or loss of follow-up after the last visit or withdrawal of consent.

Conditions
Solid Tumors
Being tested
Atezolizumab, Selicrelumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtezolizumabDrug

    Also called MPDL3280A, Tecentriq

    Atezolizumab will be administered as per the dosage regimen mentioned in respective arm descriptions.

  • SelicrelumabDrug

    Also called RO7009789

    Selicrelumab will be administered as per the dosage regimen mentioned in respective arm descriptions.

Study groups in NCT02304393
Study groupRoleWhat they receive
Part IA: Selicrelumab (IV) + AtezolizumabExperimentalSelicrelumab at a dose of 16 milligrams (mg) will be administered intravenously (IV) on Day 1 of Cycle 1 (first cycle in this group was of 42 days, and subsequent 21-day cycles); and atezolizumab 1200 mg will be administered IV after 6 weeks on Day 1 of Cycle 2, followed by every 3 weeks during Part IA until disease progression, death, loss of follow-up, or withdrawal of consent.
Receives: Drug: Atezolizumab; Drug: Selicrelumab
Part IA: Selicrelumab(SC) + AtezolizumabExperimentalSelicrelumab at a starting dose of 1 mg will be administered subcutaneously (SC) on Day 1 of Cycle 1 (21-day cycle) which will follow escalation in sequential cohorts; and atezolizumab 1200 mg will be administered IV on Day 1 of Cycle 2, and followed by every 3 weeks during Part IA as long as the participant experiences clinical benefit in the opinion of the investigator or until unacceptable toxicity.
Receives: Drug: Atezolizumab; Drug: Selicrelumab
Part IB: Selicrelumab + AtezolizumabExperimentalSelicrelumab will be administered at a starting dose of 1 mg SC on Day 2 of Cycle 1 (21-day cycle) which will follow escalation in sequential cohorts; and atezolizumab 1200 mg will be administered IV on Day 1 of Cycle 1, and followed by every 3 weeks during Part IB as long as the participant experiences clinical benefit in the opinion of the investigator or until unacceptable toxicity.
Receives: Drug: Atezolizumab; Drug: Selicrelumab
Part II: Selicrelumab + AtezolizumabExperimentalAtezolizumab 1200 mg will be administered IV on Day 1 of Cycle 1, and followed by every 3 weeks; and Selicrelumab will be administered at the dose defined in Part IB (not exceeding 80 mg SC [unless IV administration in Part IB demonstrates better benefit/risk ratio]) on Day 2 (1 day after atezolizumab administration) of every second cycle from Cycles 1 to 7, and every fourth cycle thereafter during Part II as long as the participant experiences clinical benefit in the opinion of the investigator or until unacceptable toxicity.
Receives: Drug: Atezolizumab; Drug: Selicrelumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part IA: Percentage of Participants with Adverse Events and Serious Adverse Events

    Measured: Baseline up to 28 Days After the Last Dose (Approximately 38 Months)

  2. Part IB: Percentage of Participants with Adverse Events and Serious Adverse Events

    Measured: Baseline up to 28 Days After the Last Dose (Approximately 38 Months)

  3. Part IB: Percentage of Participants With Dose-Limiting Toxicities (DLTs)

    Measured: Cycle 1 Day 1 up to Cycle 2 Day 2 (Cycle length = 21 days)

  4. Part IB: Maximum Tolerated Dose (MTD) of Selicrelumab

    Measured: Cycle 1 Day 1 up to Cycle 2 Day 2 (Cycle length = 21 days)

  5. Part IB: Recommended Part II Dose of Selicrelumab

    Measured: Cycle 1 Day 1 up to Cycle 2 Day 2 (Cycle length = 21 days)

  6. Part II: Percentage of Participants with Adverse Events and Serious Adverse Events

    Measured: Baseline up to 28 days after the last dose (approximately 38 months)

  7. Part II: Percentage of Participants With Best Overall Response, as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

    Measured: Baseline up to PD or death due to any cause, whichever occurs first (up to approximately 38 months)

  8. Part II: Progression-Free Survival (PFS), as Determined by Investigator Using RECIST Version 1.1

    Measured: Baseline up to PD or death due to any cause, whichever occurs first (up to approximately 38 months)

  9. Part II: Duration of Objective Response, as Determined by Investigator Using RECIST Version 1.1

    Measured: Baseline up to PD or death due to any cause, whichever occurs first (up to approximately 38 months)

  10. Part II: Percentage of Participants With Disease Control, as Determined by Investigator Using RECIST Version 1.1

    Measured: Baseline up to PD or death due to any cause, whichever occurs first (up to approximately 38 months)

  11. Part II: Percentage of Participants With Disease Control, as Determined by Investigator Using Unidimensional irRC

    Measured: Baseline up to PD or death due to any cause, whichever occurs first (up to approximately 38 months)

  12. Part II: PFS, as Determined by Investigator Using Unidimensional irRC

    Measured: Baseline up to PD or death due to any cause, whichever occurs first (up to approximately 38 months)

  13. Part II: Percentage of Participants With Best Overall Response, as Determined by Investigator Using Unidimensional Immune-Related Response Criteria (irRC)

    Measured: Baseline up to PD or death due to any cause, whichever occurs first (up to approximately 38 months)

  14. Part II: Duration of Objective Response, as Determined by Investigator Using Unidimensional irRC

    Measured: Baseline up to PD or death due to any cause, whichever occurs first (up to approximately 38 months)

  15. Part II: Overall Survival

    Measured: Baseline up to death due to any cause (up to approximately 38 months)

Secondary outcomes (58)

  1. Part IA: Area Under the Concentration Time Curve (AUC) of Selicrelumab

    Measured: Pre Selicrelumab dose (1hour[Hr]) on Cycle(Cy)1 Day1(D1); 4,8,24,48,72Hr post D1dose; D8,15 of Cy1; D1 Cy2&3 (10 minutes pre ATZ dose); at radiographic disease progression (PD)(up to 38 months);28&150 days after last ATZ dose (up to38months)(Cy=21days)

  2. Part IA: Maximum Serum Concentration (Cmax) of Selicrelumab

    Measured: Pre Selicrelumab dose (within 1 Hr) on Cy1 D1; 4, 8, 24, 48,72Hr post D1dose; D8, D15 of Cy1; D1 of Cy2 & 3 (10 minutes [min] pre ATZ dose); at radiographic PD (up to 38 months); 28 & 150 days after last ATZ dose (up to 38 months) (Cy=21days)

  3. Part IA: Time to Cmax (Tmax) of Selicrelumab

    Measured: Pre Selicrelumab dose (within 1 Hr) on Cy1 D1; 4, 8, 24, 48,72Hr post D1dose; D8, D15 of Cy1; D1 of Cy2 & 3 (10 min pre ATZ dose); at radiographic PD (up to 38 months); 28 & 150 days after last ATZ dose (up to 38 months) (Cy=21days)

  4. Part IA: Minimum Serum Concentration Under Steady-State (Cmin) of Selicrelumab

    Measured: Pre Selicrelumab dose (within 1 Hr) on Cy1 D1; 4, 8, 24, 48,72Hr post D1dose; D8, D15 of Cy1; D1 of Cy2 & 3 (10 min pre ATZ dose); at radiographic PD (up to 38 months); 28 & 150 days after last ATZ dose (up to 38 months) (Cy=21days)

  5. Part IA: Apparent Clearance (CL/F) of Selicrelumab

    Measured: Pre Selicrelumab dose (within 1 Hr) on Cy1 D1; 4, 8, 24, 48,72Hr post D1dose; D8, D15 of Cy1; D1 of Cy2 & 3 (10 min pre ATZ dose); at radiographic PD (up to 38 months); 28 & 150 days after last ATZ dose (up to 38 months) (Cy=21days)

  6. Part IA: Half-Life (t1/2) of Selicrelumab

    Measured: Pre Selicrelumab dose (within 1 Hr) on Cy1 D1; 4, 8, 24, 48,72Hr post D1dose; D8, D15 of Cy1; D1 of Cy2 & 3 (10 min pre ATZ dose); at radiographic PD (up to 38 months); 28 & 150 days after last ATZ dose (up to 38 months) (Cy=21days)

  7. Part IA: Cmax of Atezolizumab

    Measured: Pre ATZ (within 10 min) & at end of 60 min ATZ infusion on Cy2D1; pre ATZ dose (within 10 min) on D1 of Cy3,4,5,9,& every 8Cy thereafter(up to 38 months); at radiographic PD(up to 38 months); 28&150 days after last ATZ dose (up to 38 months) (Cy=21 days)

  8. Part IA: Cmin of Atezolizumab

    Measured: Pre ATZ (within 10 min) & at end of 60 min ATZ infusion on Cy2D1; pre ATZ dose (within 10 min) on D1 of Cy3,4,5,9,& every 8Cy thereafter(up to 38 months); at radiographic PD(up to 38 months); 28&150 days after last ATZ dose (up to 38 months) (Cy=21 days)

  9. Part IB: AUC of SC Selicrelumab

    Measured: Pre ATZ dose (within 1 Hr) on Cy1D1, Pre Selicrelumab dose (within 1 Hr) on Cy1D2; Cy1 D3,4,5,9,15 post D2 dose; D1 of Cy2 & 3 (10 min pre ATZ dose); at radiographic PD (up to 38 months); 28 & 150 days after last ATZ dose (up to 38 months) (Cy=21 days)

  10. Part IB: Cmax of SC Selicrelumab

    Measured: Pre ATZ dose (within 1 Hr) on Cy1D1, Pre Selicrelumab dose (within 1 Hr) on Cy1D2; Cy1 D3,4,5,9,15 post D2 dose; D1 of Cy2 & 3 (10 min pre ATZ dose); at radiographic PD (up to 38 months); 28 & 150 days after last ATZ dose (up to 38 months) (Cy=21 days)

  11. Part IB: Tmax of SC Selicrelumab

    Measured: Pre ATZ dose (within 1 Hr) on Cy1D1, Pre Selicrelumab dose (within 1 Hr) on Cy1D2; Cy1 D3,4,5,9,15 post D2 dose; D1 of Cy2 & 3 (10 min pre ATZ dose); at radiographic PD (up to 38 months); 28 & 150 days after last ATZ dose (up to 38 months) (Cy=21 days)

  12. Part IB: Cmin of SC Selicrelumab

    Measured: Pre ATZ dose (within 1 Hr) on Cy1D1, Pre Selicrelumab dose (within 1 Hr) on Cy1D2; Cy1 D3,4,5,9,15 post D2 dose; D1 of Cy2 & 3 (10 min pre ATZ dose); at radiographic PD (up to 38 months); 28 & 150 days after last ATZ dose (up to 38 months) (Cy=21 days)

  13. Part IB: CL/F of SC Selicrelumab

    Measured: Pre ATZ dose (within 1 Hr) on Cy1D1, Pre Selicrelumab dose (within 1 Hr) on Cy1D2; Cy1 D3,4,5,9,15 post D2 dose; D1 of Cy2 & 3 (10 min pre ATZ dose); at radiographic PD (up to 38 months); 28 & 150 days after last ATZ dose (up to 38 months) (Cy=21 days)

  14. Part IB: Apparent Volume of Distribution (V/F) of SC Selicrelumab

    Measured: Pre ATZ dose (within 1 Hr) on Cy1D1, Pre Selicrelumab dose (within 1 Hr) on Cy1D2; Cy1 D3,4,5,9,15 post D2 dose; D1 of Cy2 & 3 (10 min pre ATZ dose); at radiographic PD (up to 38 months); 28 & 150 days after last ATZ dose (up to 38 months) (Cy=21 days)

  15. Part IB: t1/2 of SC Selicrelumab

    Measured: Pre ATZ dose (within 1 Hr) on Cy1D1, Pre Selicrelumab dose (within 1 Hr) on Cy1D2; Cy1 D3,4,5,9,15 post D2 dose; D1 of Cy2 & 3 (10 min pre ATZ dose); at radiographic PD (up to 38 months); 28 & 150 days after last ATZ dose (up to 38 months) (Cy=21 days)

  16. Part IB: Cmax of Atezolizumab

    Measured: Pre ATZ (within 1 Hr) & at end of 60 min ATZ infusion on Cy1D1; pre ATZ dose (within 10 min) on D1 of Cy2,3,4,8,& every 8Cy thereafter (up to 38 months); at radiographic PD (up to 38 months); 28&150 days after last ATZ dose (up to 38 months) (Cy=21 days)

  17. Part IB: Cmin of Atezolizumab

    Measured: Pre ATZ (within 1 Hr) & at end of 60 min ATZ infusion on Cy1D1; pre ATZ dose (within 10 min) on D1 of Cy2,3,4,8,& every 8Cy thereafter (up to 38 months); at radiographic PD (up to 38 months); 28&150 days after last ATZ dose (up to 38 months) (Cy=21 days)

  18. Part II: AUC of Selicrelumab

    Measured: Pre Selicrelumab (within 1Hr) on Cy1D2; Cy1,5D5,8,15; pre ATZ (10 min) on D1-Cy2,4,6,8 and thereafter except Cy 11, 15, 19; pre Selicrelumab(10 min) on D2 of Cy3,5,11,15,19; D8 of Cy11,15,19; 28&150 days after last ATZ (up to 38 months) (Cy=21days)

  19. Part II: Cmax of Selicrelumab

    Measured: Pre Selicrelumab (within 1Hr) on Cy1D2; Cy1, 5D5, 8, 15; pre ATZ (10 min) on D1-Cy2,4,6,8 and thereafter except Cy 11, 15, 19; pre Selicrelumab(10 min) on D2-Cy3,5,11,15,19; D8-Cy 11,15,19; 28&150 days after last ATZ (up to 38 months) (Cy=21days)

  20. Part II: Tmax of Selicrelumab

    Measured: Pre Selicrelumab (within 1Hr) on Cy1D2; Cy 1, 5 D5,8,15; pre ATZ (10 min) on D1-Cy2,4,6,8 and thereafter except Cy 11, 15, 19; pre Selicrelumab(10 min) on D2 of Cy3,5,11,15,19; D8 of Cy 11,15,19; 28&150 days after last ATZ (up to 38 months) (Cy=21days)

  21. Part II: Cmin of Selicrelumab

    Measured: Pre Selicrelumab (within 1Hr) on Cy1D2; Cy1,5D5, 8,15; pre ATZ (10 min) on D1-Cy2,4,6,8 and thereafter except Cy11, 15, 19; pre Selicrelumab(10 min) on D2-Cy3,5,11,15,19; D8-Cy 11,15,19; 28&150 days after last ATZ (up to 38 months) (Cy=21days)

  22. Part II: CL/F of Selicrelumab

    Measured: Pre Selicrelumab (within 1Hr) on Cy1D2; Cy1,5D5,8,15; pre ATZ (10 min) on D1-Cy2,4,6,8 and thereafter except Cy 11, 15, 19; pre Selicrelumab(10 min) on D2-Cy3,5,11,15,19; D8-Cy11,15,19; 28&150 days after last ATZ (up to 38 months) (Cy=21days)

  23. Part II: V/F of Selicrelumab

    Measured: Pre Selicrelumab (within 1Hr) on Cy1D2; Cy 1,5D5,8,15; pre ATZ (10 min) on D1-Cy2,4,6,8 and thereafter except Cy 11, 15, 19; pre Selicrelumab(10 min) on D2-Cy3,5,11,15,19; D8-Cy 11,15,19; 28&150 days after last ATZ (up to 38 months) (Cy=21days)

  24. Part II: t1/2 of Selicrelumab

    Measured: Pre Selicrelumab (within 1Hr) on Cy1D2; Cy1,5D5,8,15; pre ATZ (10 min) on D1-Cy2,4,6,8 and thereafter except Cy 11, 15, 19; pre Selicrelumab(10 min) on D2-Cy3,5,11,15,19; D8-Cy 11,15,19; 28&150 days after last ATZ (up to 38 months) (Cy=21days)

  25. Part II: Cmax of Atezolizumab

    Measured: Cy1D1: pre ATZ dose (within 1 Hr), at end of ATZ infusion (60 min infusion); pre-ATZ dose (within 10 min)on D1 Cy2, 3, 4, 5, 6, 8, and thereafter (up to 38 months); 28 and 150 days after last ATZ dose (up to 38 months) (Cy = 21 days)

  26. Part II: Cmin of Atezolizumab

    Measured: Cy1D1: pre ATZ dose (within 1 Hr), at end of ATZ infusion (60 min infusion); pre-ATZ dose (within 10 min)on D1 Cy2, 3, 4, 5, 6, 8, and thereafter (up to 38 months); 28 and 150 days after last ATZ dose (up to 38 months) (Cy = 21 days)

  27. Part IB: Percentage of Participants With Best Overall Response, as Determined by Investigator Using Unidimensional Immune-Related Response Criteria (irRC)

    Measured: Baseline up to PD or death due to any cause, whichever occurs first (up to approximately 38 months)

  28. Part IB: Percentage of Participants With Best Overall Response, as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

    Measured: Baseline up to PD or death due to any cause, whichever occurs first (up to approximately 38 months)

  29. Part IB: Percentage of Participants With Disease Control, as Determined by Investigator Using RECIST Version 1.1

    Measured: Baseline up to PD or death due to any cause, whichever occurs first (up to approximately 38 months)

  30. Part Ib: Percentage of Participants With Disease Control, as Determined by Investigator Using Unidimensional irRC

    Measured: Baseline up to PD or death due to any cause, whichever occurs first (up to approximately 38 months)

  31. Part IB: Duration of Objective Response, as Determined by Investigator Using RECIST Version 1.1

    Measured: First occurrence of response up to relapse or death due to any cause, whichever occurs first (up to approximately 38 months)

  32. Part Ib: Duration of Objective Response, as Determined by Investigator Using Unidimensional irRC

    Measured: First occurrence of response up to relapse or death due to any cause, whichever occurs first (up to approximately 38 months)

  33. Part IB: Progression-Free Survival (PFS), as Determined by Investigator Using RECIST Version 1.1

    Measured: Baseline up to PD or death due to any cause, whichever occurs first (up to approximately 38 months)

  34. Part IA, IB, and II: Percentage of Participants With Auto-antibodies

    Measured: Pre Selicrelumab dose(within 1 Hr) on Cy1D1;pre ATZ dose(within 10 min) on D1 Cy2,3,4,5 and every 8 cycles thereafter, up to 38 months); at radiographic PD (up to 38 months); 28 & 150 days after last ATZ dose (up to 38 months overall) (Cy=21 days)

  35. Part IA, IB, and II: Percentage of Participants With Anti-Therapeutic Antibodies (ATA) to Selicrelumab

    Measured: Pre Selicrelumab dose(within 1 Hr) on Cy1D1;pre ATZ dose(within 10 min) on D1 Cy2,3,4,5 and every 8 cycles thereafter, up to 38 months); at radiographic PD (up to 38 months); 28 & 150 days after last ATZ dose (up to 38 months overall) (Cy=21 days)

  36. Part IA, IB, and II: Percentage of Participants With ATA to ATZ

    Measured: Pre ATZ(within 10 min)on D1 Cy2,3,4,5(Part IA),9(Cy8 for Part II)& every 8 cycles thereafter(up to 38 months);pre ATZ(within 1Hr) on Cy1D1(for Part IB & II);at radiographic PD(up to 38 months),28&150 days after last ATZ dose(up to 38 months)(Cy=21 days)

  37. Part IA: Levels of Circulating Ki67 T cells Assessed by Immunophenotyping by Flow Cytometry

    Measured: Cy1 D1: predose Selicrelumab D4 D8 D15 Cy2 D1: predose Atezo D3 D8 Cy3 D1: predose Atezo D8 PD at IRR/ISR (Cy=21 Days)

  38. Part IB: Levels of Circulating Ki67 T Cells Assessed by Immunophenotyping by Flow Cytometry

    Measured: Cy1: D3 D4 D5 D9 D15; Cy2: D1 D8; Cy4-47: D1 PD at IRR/ISR (Cy = 21 days)

  39. Part II: Levels of Circulating Ki67 T Cells Assessed by Immunophenotyping by Flow Cytometry

    Measured: Cy1: D1 pre-Atezo, D8, D15; Cy2D1: pre-Atezo; Cy3 D1 pre-Atezo, D8; Cy4D1: pre-Atezo; Cy5: D1 pre-Atezo, D8, D15; Cy6D1: Pre-Atezo; Cy11, 15 and 19: D1 pre Atezo and D8; After last Atezo dose SFU at IRR/ISR (Cy= 21 Days)

  40. Part IA: Levels of Cluster of Differentiation 8 (CD8+) Cells Tumor-Infiltration Assessed by Immunophenotyping by Flow Cytometry

    Measured: Cy1 D1: predose Selicrelumab D4 D8 D15; Cy2 D1: predose Atezo D3 D8; Cy3 D1: predose Atezo D8 PD at IRR/ISR (Cy= 21 Days)

  41. Part IB: Levels of CD8+ Cells Tumor-Infiltration Assessed by Immunophenotyping by Flow Cytometry

    Measured: Cy1: D1 predose, D3, D4, D5, D9, D15; Cy2: D1 predose, D8; Cy4-47: D1 predose, PD at IRR/ISR (Cy = 21 days)

  42. Part IA: Levels of Programmed Death Ligand 1 (PD-L1) Expression on Both Tumor and Immune-Infiltrating Cells Assessed by Immunophenotyping by Flow Cytometry

    Measured: Cy1 D1: predose Selicrelumab D4 D8 D15; Cy2 D1: predose Atezo D3 D8; Cy3 D1: predose Atezo D8 PD at IRR/ISR (Cycle = 21 Days)

  43. Part IB: Levels of PD-L1 Expression on Both Tumor and Immune-Infiltrating Cells Assessed by Immunophenotyping by Flow Cytometry

    Measured: Cy1: D1 predose, D3, D4, D5, D9, D15; Cy2: D1 predose, D8; Cy4-47: D1 predose, PD at IRR/ISR (Cy = 21 days)

  44. Part II: Levels of PD-L1 Expression on Both Tumor and Immune-Infiltrating Cells Assessed by Immunophenotyping by Flow Cytometry

    Measured: Cy1: D1 pre-Atezo, D8, D15; Cy2D1: pre-Atezo; Cy3 D1 pre-Atezo, D8; Cy4D1: pre-Atezo; Cy5: D1 pre-Atezo, D8, D15; Cy6D1: Pre-Atezo; Cy11, 15 and 19: D1 pre-Atezo and D8; After last Atezo dose SFU at IRR/ISR (Cy= 21 Days)

  45. Part IA: V/F of Selicrelumab

    Measured: Pre Selicrelumab dose (within 1 Hr) on Cy1 D1; 4, 8, 24, 48,72Hr post D1dose; D8, D15 of Cy1; D1 of Cy2 & 3 (10 min pre ATZ dose); at radiographic PD (up to 38 months); 28 & 150 days after last ATZ dose (up to 38 months) (Cy=21days)

  46. Part IB: PFS, as Determined by Investigator Using Unidimensional irRC

    Measured: Baseline up to PD or death due to any cause, whichever occurs first (up to approximately 38 months)

  47. Part II: Levels of CD8+ Cells Tumor-Infiltration Assessed by Immunophenotyping by Flow Cytometry

    Measured: Part II: Pre ATZ (within 1 Hr) Cy1, 6, 11, 15, 19 D1; Cy1 D8, 15; pre ATZ (within 10 min) Cy2, 3, 4, 5 D1; Cy3, 5, 11, 15, 19 D8; Cy 5 D15; 28 days after last ATZ dose(up to 38 months); at radiographic tumor regression/PD (up to 38 months) (Cy= 21 days)

  48. Part IB: AUC of IV Selicrelumab

    Measured: Pre ATZ(1 Hr) Cy1D1,2;end of 30-min Selicrelumab infusion,0.25,2,4,6,8,10Hr post infusion start Cy1D2;24,30-36,48,72Hr Post Cy1D2 dose;Cy 1D9;D1 Cy2,3(10min pre ATZ);at radiographic PD(up to 38mon);28&150days after last ATZ dose(up to38mon)(Cy=21days)

  49. Part IB: Cmax of IV Selicrelumab

    Measured: Pre ATZ(1 Hr)Cy1D1,2;end of 30-min Selicrelumab infusion,0.25,2,4,6,8,10Hr post infusion start Cy1D2;24,30-36,48,72Hr Post Cy1D2 dose;Cy 1D9;D1 Cy2,3(10min pre ATZ);at radiographic PD(up to 38mon);28&150days after last ATZ dose(up to38mont)(Cy=21days)

  50. Part IB: Cmin of IV Selicrelumab

    Measured: Pre ATZ(1 Hr) Cy1D1,2;end of 30-min Selicrelumab infusion,0.25,2,4,6,8,10Hr post infusion start Cy1D2;24,30-36,48,72Hr Post Cy1D2 dose;Cy 1D9;D1 Cy2,3(10min pre ATZ);at radiographic PD(up to 38mon);28&150days after last ATZ dose(up to38mon)(Cy=21days)

  51. Part IB: Total Clearance (CL) of IV Selicrelumab

    Measured: Pre ATZ(1 Hr) Cy1D1,2;end of 30-min Selicrelumab infusion,0.25,2,4,6,8,10Hr post infusion start Cy1D2;24,30-36,48,72Hr Post Cy1D2 dose;Cy 1D9;D1 Cy2,3(10min pre ATZ);at radiographic PD(up to 38mon);28&150days after last ATZ dose(up to38mon)(Cy=21days)

  52. Part IB: Volume of Distribution (Vss) of IV Selicrelumab

    Measured: Pre ATZ(1 Hr) Cy1D1,2;end of 30-min Selicrelumab infusion,0.25,2,4,6,8,10Hr post infusion start Cy1D2;24,30-36,48,72Hr Post Cy1D2 dose;Cy 1D9;D1 Cy2,3(10min pre ATZ);at radiographic PD(up to 38mon);28&150days after last ATZ dose(up to38mon)(Cy=21days)

  53. Part IB: t1/2 of IV Selicrelumab

    Measured: Pre ATZ(1 Hr) Cy1D1,2;end of 30-min Selicrelumab infusion,0.25,2,4,6,8,10Hr post infusion start Cy1D2;24,30-36,48,72Hr Post Cy1D2 dose;Cy 1D9;D1 Cy2,3(10min pre ATZ);at radiographic PD(up to 38mon);28&150days after last ATZ dose(up to38mon)(Cy=21days)

  54. Part IA: Percentage of Participants with Incidence of ADA Responses to RO7009789

    Measured: Pre-Dose Day 1 on Cycles 1, 2, 3, 4, 7 (Cycle length = 21 days); Safety Follow-up Visit (Up to 52 Days Post Final Dose)

  55. Part IA: Percentage of Participants with Incidence of ADA Responses to Vanucizumab

    Measured: Pre-Dose Day 1 on Cycles 1, 2, 4, 6, 8 (Cycle length = 21 days); Safety Follow-up Visit (Up to 52 Days Post Final Dose)

  56. Part IB: Percentage of Participants with Incidence of ADA Responses to RO7009789

    Measured: Pre-Dose Day 1 on Cycles 1, 2, 3, 4, 7 (Cycle length = 21 days); Safety Follow-up Visit (Up to 52 Days Post Final Dose)

  57. Part IB: Percentage of Participants with Incidence of ADA Responses to Vanucizumab

    Measured: Pre-Dose Day 1 on Cycles 1, 2, 4, 6, 8 (Cycle length = 21 days); Safety Follow-up Visit (Up to 52 days post final dose)

  58. Part II: Percentage of Participants with Incidence of ADA Responses to RO7009789

    Measured: Pre-Dose Day 1 on Cycles 1, 2, 3, 4, 7 (Cycle length = 21 days); Safety Follow-up Visit (Up to 52 Days Post Final Dose)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2014 (estimated)
  2. Study start12 Dec 2014
  3. Primary completion7 Nov 2019
  4. Study completion7 Nov 2019

Resources

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02304393
Sponsor's protocol ID
BP29392
Other IDs
2014-002835-32, 2014
Status last verified
Dec 2019
First submitted
26 Nov 2014
Last updated
13 Dec 2019
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Atezolizumab and Selicrelumab in people with Solid Tumors, run by Hoffmann-La Roche at 11 sites in 6 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 11 inclusion and 38 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: finished, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in France, Canada, Netherlands, Spain, United States and 1 more country. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Part IA: Percentage of Participants with Adverse Events and Serious Adverse Events (time frame: Baseline up to 28 Days After the Last Dose (Approximately 38 Months)). The study lists 15 primary outcomes in all. 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 NCT02304393.

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 13 Dec 2019.

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