Solid CancersPhase 1NCT02174172
A Study to Assess the Safety and Tolerability of Atezolizumab in Combination With Other Immune-Modulating Therapies in Participants With Locally Advanced or Metastatic Solid Tumors
A Phase 1 study testing Atezolizumab, Bevacizumab and Interferon alfa-2b in people with Solid Cancers, run by Hoffmann-La Roche at 9 sites in 2 countries.
Trial summary
This global, multicenter, open-label study will evaluate the safety and tolerability of atezolizumab in combination with other immune-modulating therapies in the treatment of selected advanced or metastatic malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Cancers
- What is being tested?
- Atezolizumab, Bevacizumab and Interferon alfa-2b
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 18 Aug 2014to 25 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 or cytologically documented locally advanced or metastatic solid tumors meeting the following study drug-specific criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Life expectancy greater than or equal to (>/=) 12 weeks
- Measurable disease, as defined by RECIST v1.1
- Adequate hematologic and end organ function as confirmed by laboratory results within 14 days prior to the first study treatment
- Inclusion criteria specific to Arm A: Atezolizumab+ Ipilimumab
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- Escalation stage: NSCLC participants
- Mandatory biopsy cohort: NSCLC or melanoma atezolizumab
- Prior atezolizumab-treated cohort: participants with NSCLC or melanoma previously treated with atezolizumab
- Inclusion criteria specific to Arm B: Atezolizumab+ Interferon alfa-2b
- Escalation stage: RCC or melanoma participants
- Expansion stage: RCC or melanoma participants
- Mandatory biopsy cohort: RCC or melanoma participants
- Prior immunotherapy-treated cohort: participants with RCC, NSCLC, or melanoma previously treated with programmed death-ligand 1 (PD-L1)/ Programmed death 1 (PD-1)
- Inclusion Criteria Specific to Arm C (Atezolizumab plus PEG-Interferon Alafa-2a):
- Cohort 1: participants with RCC
- Inclusion Criteria Specific to Arm D (Atezolizumab plus PEG-Interferon Alfa-2a +Bevacizumab)
- Cohort 1: participants with metastatic RCC with no prior line of systemic therapy for metastatic disease
- Cohorts 2-3: disease progression during or after at least one previous systemic, anti-cancer treatment for locally advanced or metastatic non-squamous solid tumors; participants with sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements must have failed or are intolerant to prior treatment with EGFR or ALK inhibitors; participants with melanoma with actionable BRAF mutations (e.g., V600) must have failed or are intolerant to prior treatment with BRAF inhibitors
- Inclusion Criteria Specific to Arm E (Atezolizumab +Obinutuzumab)
- R/M HNSCC participants with at least one prior line of systemic therapy
- Inclusion Criteria Specific to prior Anti-PD-L1/PD-1 Treated Cohorts:
- No permanent discontinuation of atezolizumab or other immunotherapies due to a treatment-related adverse event
- Recovery from all immunotherapy-related adverse events to Grade less than or equal to (≤) 1 or baseline at the time of consent
Who cannot join
- General Medical Exclusions:
- Pregnant and lactating women
- Any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3 weeks prior to initiation of study treatment, with the following exception: (1) hormone-replacement therapy or oral contraceptives; (2) tyrosine kinase inhibitors (TKIs) that have been discontinued greater than (>) 7 days prior to Cycle 1, Day 1, baseline scans must be obtained after discontinuation of prior TKIs
- Investigational therapy within 28 days prior to initiation of study treatment
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- Known hypersensitivity or allergy to Chinese hamster ovary cell products or any component of the atezolizumab formulation
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- History of or active autoimmune disease
- History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia, risk of pulmonary toxicity, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
- Prior allogeneic bone marrow transplantation or prior solid organ transplantation
- History of human immunodeficiency virus (HIV)
- Participants with active hepatitis B
- Participants with active hepatitis C
- Participants with active tuberculosis
- Participants with a history of confirmed progressive multifocal leukoencephalopathy
- Any serious medical condition, physical examination finding, or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study
- Cancer-Specific Exclusions:
- Active or untreated central nervous system (CNS) metastases, as determined by CT or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments
- 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 prior to screening
- Leptomeningeal disease
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently); participants with indwelling catheters are allowed.
- Uncontrolled tumor-related pain
- Uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab
- History of other malignancy within 2 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, localized prostate cancer treated with curative intent, ductal carcinoma in situ treated surgically with curative intent, or other cancers with a similar outcome
- Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies (Note: Participants enrolled in the prior anti-PD-L1/PD-1 treated cohorts with melanoma may have received prior anti-cytotoxic T-lymphocyte-associated protein 4 treatment or other immunotherapies)
- Treatment with systemic immunostimulatory agents within four weeks or five half-lives of the drug, whichever is shorter, prior to Cycle 1, Day 1
- Treatment with systemic immunosuppressive medications within 2 weeks prior to Cycle 1, Day 1 (the use of inhaled corticosteroids and mineralocorticoids is allowed)
- Exclusion Criteria Specific to Interferon Alpha Therapy (Arms B-D):
- History of depression, suicidal ideation or behavior, bipolar disorder, or psychosis
- Hypersensitivity to interferon alpha or any component of the product
- Inadequately controlled hypertension
- Prior history of hypertensive crisis or hypertensive encephalopathy
- Significant vascular disease within 6 months prior to Day 1
- History of hemoptysis
- Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
- History of tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 1
- Clinical signs or symptoms of gastrointestinal obstruction or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding
- Evidence of abdominal free air that is not explained by paracentesis or recent surgical procedure
- Proteinuria, as demonstrated by urine dipstick or > 1.0 gram of protein in a 24-hour urine collection
- Metastatic disease that involves major airways or blood vessels, or centrally located mediastinal tumor masses of large volume
- Hypersensitivity to obinutuzumab
- Prior treatment with obinutuzumab
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States8 sites
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Mayo Clinic-Jacksonville
Jacksonville, Florida, 32224
UCLA
Los Angeles, California, 90095
Sarah Cannon Research Inst.
Nashville, Tennessee, 37203
Vanderbilt Medical Center
Nashville, Tennessee, 37232-7610
Yale University
New Haven, Connecticut, 06510
HonorHealth Research Institute - Bisgrove
Scottsdale, Arizona, 85258
Mayo Clinic- Scottsdale
Scottsdale, Arizona, 85259
Netherlands1 site
The Netherlands Cancer Institute of Amsterdam
Amsterdam, 1066 CX
About this study
Official title: A Phase Ib Study of The Safety And Pharmacology of Atezolizumab (Anti-Pd-L1 Antibody) Administered With Ipilimumab, Interferon-Alpha, or Other Immune-Modulating Therapies in Patients With Locally Advanced or Metastatic Solid Tumors
This global, multicenter, open-label study will evaluate the safety and tolerability of atezolizumab in combination with other immune-modulating therapies in the treatment of selected advanced or metastatic malignancies. The atezolizumab plus ipilimumab arm (Arm A) will focus primarily on participants with advanced or metastatic non-small cell lung cancer (NSCLC). The atezolizumab plus interferon alfa-2b arm (Arm B), plus pegylated interferon alfa-2a (PEG-interferon alfa-2a, Arm C), and atezolizumab plus PEG-interferon Alfa-2a plus bevacizumab (Arm D) will enroll participants with advanced or metastatic renal cell carcinoma (RCC), metastatic NSCLC and melanoma. The atezolizumab plus obinutuzumab) (Arm E) will enroll participants with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). Atezolizumab will be administered as intravenous (IV) infusion every 3 weeks (q3w).
- Conditions
- Solid Cancers
- Being tested
- Atezolizumab, Bevacizumab, Interferon alfa-2b, Ipilimumab, Obinutuzumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtezolizumabDrug
Also called Tecentriq, RO5541267, MPDL3280A
Participant will receive atezolizumab 600 milligrams (mg) or 1200 mg by IV infusion q3w.
BevacizumabDrug
Also called Avastin®
Participant will receive Bevacizumab 15 milligrams per kilograms (mg/kg) IV infusion q3w.
Interferon alfa-2bDrug
Participants will receive Interferon alfa-2b 3, 5, or 10 million international units subcutaneously every other day for up to 3 doses per week.
IpilimumabDrug
Participants will receive Ipilimumab 1, or 3 mg/kg IV, single dose, or multiple-dose regimen q3w for up to 4 cycles (Cycle = 21 days).
ObinutuzumabDrug
Obinutuzumab 1000 milligrams will be administered as pre-treatment on 2 consecutive days (Day -13 and Day -12) prior to treatment start with atezolizumab on Cycle 1, Day 1 (cycle length=21 days). An additional two doses of obinutuzumab will be administered on Days 85 and 86 of study treatment (Cycle 5, Day 1 and Cycle 5, Day 2).
PEG-interferon alfa-2aDrug
Also called Pegasys®
Participant will receive PEG-interferon alfa-2a 180 micrograms subcutaneous injection q3w for a total of 6 cycles (Cycle = 21 days).
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Atezolizumab with Ipilimumab | Experimental | Participants will receive atezolizumab along with ipilimumab. Receives: Drug: Atezolizumab; Drug: Ipilimumab |
| Arm B: Atezolizumab with Interferon alfa-2b | Experimental | Participants will receive atezolizumab along with Interferon alfa-2b. Receives: Drug: Atezolizumab; Drug: Interferon alfa-2b |
| Arm C: Atezolizumab with PEG- interferon alfa-2a | Experimental | Participants will receive atezolizumab along with PEG- interferon alfa-2a. Receives: Drug: Atezolizumab; Drug: PEG-interferon alfa-2a |
| Arm D:Atezolizumab with PEG-interferon alfa-2a and Bevacizumab | Experimental | Participants will receive atezolizumab along with PEG- interferon alfa-2a and bevacizumab. Receives: Drug: Atezolizumab; Drug: Bevacizumab; Drug: PEG-interferon alfa-2a |
| Arm E: Atezolizumab with Obinutuzumab | Experimental | Participants will receive atezolizumab along with obinutuzumab or atezolizumab alone. Receives: Drug: Atezolizumab; Drug: Obinutuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended Phase II Dose (RP2D) of Atezolizumab When Given in Combination With Ipilimumab and Interferon Alfa-2b
Measured: From the first atezolizumab treatment up to 21 days
Percentage of Participants with Adverse Events
Measured: From the first atezolizumab treatment up to 4.5 years (yr)
Secondary outcomes (15)
Percentage of Participants with Best Overall Response, as Assessed Using Conventional Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measured: Screening to progression or death, up to 4.5 yr (assessed at baseline, every 6 weeks for 48 weeks and every 12 weeks thereafter up to treatment completion/early termination [up to 4.5 yr])
Percentage of Participants with Best Overall Response, as Assessed Using Immune Modified RECIST Criteria
Measured: Screening to progression or death, up to 4.5 years (assessed at baseline, every 6 weeks for 48 weeks and every 12 weeks thereafter up to treatment completion/early termination [up to 4.5 yr])
Duration of Objective Response
Measured: Screening to progression or death, up to 4.5 yr (assessed at baseline, every 6 weeks for 48 weeks and every 12 weeks thereafter up to treatment completion/early termination [up to 4.5 yr])
Overall Survival
Measured: Baseline to death (up to 4.5 yr)
Progression-Free Survival
Measured: Screening to progression or death, up to 4.5 yr (assessed at baseline, every 6 weeks for 48 weeks and every 12 weeks thereafter up to treatment completion/early termination [up to 4.5 yr])
Percentage of Participants with Objective Response, as Assessed Using Conventional RECIST v1.1
Measured: Screening to progression or death, up to 4.5 yr (assessed at Baseline, every 6 weeks for 48 weeks and every 12 weeks thereafter up to treatment completion/early termination [up to 4.5 yr])
Percentage of Participants with Objective Response, as Assessed Using Immune Modified RECIST Criteria
Measured: Screening to progression or death, up to 4.5 yr (assessed at Baseline, every 6 weeks for 48 weeks and every 12 weeks thereafter up to treatment completion/early termination [up to 4.5 yr])
Serum Atezolizumab Concentration
Arm A: Predose (0 hour [hr]), 30 minutes (min) post end of infusion on Day 1;Day 8,Day 15 of Cycle (cy) 1;Predose (0 hr) on Day 1 of cy 2,3,4,8; end of treatment/withdrawal;≥ 90 days post last dose (up to 4.5 years [yr]). Arm B: Predose (0 hr) on Day 1,30 min post end of infusion on Day 8,Day 15,Day 22 of cy 1;Predose (0 hr) on Day 1 of cy 2,3,4,5,8; end of treatment/withdrawal;≥ 90 days post last dose (up to 4.5 yr). Arms C,D: Predose (0 hr), 30 min post end of infusion on Day 1 cy 1,3;Predose (0 hr) on Day 1 of cy 2,4,8, every 8 cy thereafter up to end of treatment/withdrawal;≥ 90 days post last dose (up to 4.5 yr). Arm E: Predose (0 hr), 30 min post end of infusion on Day 1 cy 1,5;Predose (0 hr) on Day 1 of cy 2,3,4,8, every 8 cy thereafter up to treatment end of treatment/withdrawal;≥ 90 days post last dose (up to 4.5 yr). Cycle length = 21 days (28 days for Arm B, cycle 1)
Measured: Baseline up to 4.5 years (detailed timeframe is given in outcome description)
Serum Ipilimumab Concentration
Predose (0 hr), 30 min post end of infusion on Day 1 of Cy 1,3;Predose on Day 1 of Cy 4; end of treatment/ withdrawal;≥ 90 days post last dose (up to 4.5 yr) Cycle length = 21 days
Measured: Baseline up to 4.5 years (detailed timeframe is given in outcome description)
Serum Bevacizumab Concentration
Predose (0 hr), 30 min post end of infusion on Day 1 of Cy 1,3; end of treatment/ withdrawal;≥ 90 days post last dose (up to 4.5 yr) Cycle length = 21 days
Measured: Baseline up to 4.5 years (detailed timeframe is given in outcome description)
Serum Obinutuzumab Concentration
Predose (0 hr), 30 min post end of infusion on Days -13, -12 and on Day 1 Cy 5; end of treatment/withdrawal;≥90 days post last dose (up to 4.5 yr) Cycle length = 21 days
Measured: Baseline up to 4.5 years (detailed outcome given in outcome description)
Anti-Drug Antibody to Atezolizumab
Detailed timeframe:
Arm A: Predose (0 hr) on Day 1 of Cy 1,2,3,4,8; end of treatment/withdrawal;≥ 90 days post last dose (up to 4.5 yr).
Arm B: Predose (0 hr) on Day 1 of Cy 1,2,3,4,5,8; end of treatment/withdrawal;≥ 90 days post last dose (up to 4.5 yr).
Arms C, D, E: Predose (0 hr) on Day 1 of cy 1,2,3,4,8, thereafter every 8 Cy up to end of treatment/ withdrawal;≥ 90 days post last dose (up to 4.5 yr).
Cycle length = 21 days (28 days for Arm B, cycle 1)
Measured: Baseline up to 4.5 years (detailed timeframe is given in outcome description)
Anti-Drug Antibody to Ipilimumab
Pre-dose (0 hr) on Day 1 of Cy 1, 4, end of treatment/ withdrawal;≥ 90 days post last dose (up to 4.5 yr) Cycle length = 21 days
Measured: Baseline up to 4.5 years (detailed timeframe is given in outcome description)
Anti-Drug Antibody to Bevacizumab
Predose (0 hr) on Day 1 of Cy 1, 3; end of treatment/withdrawal;≥ 90 days post last dose (up to 4.5 yr).
Cycle length = 21 days
Measured: Baseline up to 4.5 years (detailed timeframe is given in outcome description)
Anti-Drug Antibody to Obinutuzumab
Predose (0 hr) on Days -13 and -12; end of treatment/withdrawal;≥ 90 days post last dose (up to 4.5 yr) Cycle length = 21 days
Measured: Baseline up to 4.5 years (detailed timeframe is given in outcome description)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study start18 Aug 2014
- Primary completion25 Nov 2019
- Study completion25 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 158 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
- NCT02174172
- Sponsor's protocol ID
- GO29322
- Other IDs
- 2014-000812-33, 2014
- Status last verified
- May 2020
- First submitted
- 19 Jun 2014
- Last updated
- 12 May 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Study of The Safety And Pharmacology of Atezolizumab (Anti-Pd-L1 Antibody) Administered With Ipilimumab, Interferon-Alpha, or Other Immune-Modulating Therapies in Patients With Locally Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT02174172
- Acronym / sponsor ID
- GO29322
- Conditions
- Solid Cancers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 18 Aug 2014 (actual)
- Primary completion
- 25 Nov 2019 (actual)
- Study completion
- 25 Nov 2019 (actual)
- First posted
- 25 Jun 2014 (estimated)
- 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.
This global, multicenter, open-label study will evaluate the safety and tolerability of atezolizumab in combination with other immune-modulating therapies in the treatment of selected advanced or metastatic malignancies. The atezolizumab plus ipilimumab arm (Arm A) will focus primarily on participants with advanced or metastatic non-small cell lung cancer (NSCLC). The atezolizumab plus interferon alfa-2b arm (Arm B), plus pegylated interferon alfa-2a (PEG-interferon alfa-2a, Arm C), and atezolizumab plus PEG-interferon Alfa-2a plus bevacizumab (Arm D) will enroll participants with advanced or metastatic renal cell carcinoma (RCC), metastatic NSCLC and melanoma. The atezolizumab plus obinutuzumab) (Arm E) will enroll participants with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). Atezolizumab will be administered as intravenous (IV) infusion every 3 weeks (q3w).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm A: Atezolizumab with Ipilimumab | Experimental | Drug: Atezolizumab, Drug: IpilimumabParticipants will receive atezolizumab along with ipilimumab. |
| Arm B: Atezolizumab with Interferon alfa-2b | Experimental | Drug: Atezolizumab, Drug: Interferon alfa-2bParticipants will receive atezolizumab along with Interferon alfa-2b. |
| Arm C: Atezolizumab with PEG- interferon alfa-2a | Experimental | Drug: Atezolizumab, Drug: PEG-interferon alfa-2aParticipants will receive atezolizumab along with PEG- interferon alfa-2a. |
| Arm D:Atezolizumab with PEG-interferon alfa-2a and Bevacizumab | Experimental | Drug: Atezolizumab, Drug: Bevacizumab, Drug: PEG-interferon alfa-2aParticipants will receive atezolizumab along with PEG- interferon alfa-2a and bevacizumab. |
| Arm E: Atezolizumab with Obinutuzumab | Experimental | Drug: Atezolizumab, Drug: ObinutuzumabParticipants will receive atezolizumab along with obinutuzumab or atezolizumab alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Histologically or cytologically documented locally advanced or metastatic solid tumors meeting the following study drug-specific criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Life expectancy greater than or equal to (>/=) 12 weeks
- Measurable disease, as defined by RECIST v1.1
- Adequate hematologic and end organ function as confirmed by laboratory results within 14 days prior to the first study treatment
Key exclusion criteria (41 listed)
- Pregnant and lactating women
- Any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3 weeks prior to initiation of study treatment, with the following exception: (1) hormone-replacement therapy or oral contraceptives; (2) tyrosine kinase inhibitors (TKIs) that have been discontinued greater than (>) 7 days prior to Cycle 1, Day 1, baseline scans must be obtained after discontinuation of prior TKIs
- Investigational therapy within 28 days prior to initiation of study treatment
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- Known hypersensitivity or allergy to Chinese hamster ovary cell products or any component of the atezolizumab formulation
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 |
|---|---|---|
| AtezolizumabAlso: Tecentriq, RO5541267, MPDL3280AParticipant will receive atezolizumab 600 milligrams (mg) or 1200 mg by IV infusion q3w. | Drug | Arm A: Atezolizumab with Ipilimumab, Arm B: Atezolizumab with Interferon alfa-2b, Arm C: Atezolizumab with PEG- interferon alfa-2a, Arm D:Atezolizumab with PEG-interferon alfa-2a and Bevacizumab, Arm E: Atezolizumab with Obinutuzumab |
| BevacizumabAlso: Avastin®Participant will receive Bevacizumab 15 milligrams per kilograms (mg/kg) IV infusion q3w. | Drug | Arm D:Atezolizumab with PEG-interferon alfa-2a and Bevacizumab |
| Interferon alfa-2bParticipants will receive Interferon alfa-2b 3, 5, or 10 million international units subcutaneously every other day for up to 3 doses per week. | Drug | Arm B: Atezolizumab with Interferon alfa-2b |
| IpilimumabParticipants will receive Ipilimumab 1, or 3 mg/kg IV, single dose, or multiple-dose regimen q3w for up to 4 cycles (Cycle = 21 days). | Drug | Arm A: Atezolizumab with Ipilimumab |
| ObinutuzumabObinutuzumab 1000 milligrams will be administered as pre-treatment on 2 consecutive days (Day -13 and Day -12) prior to treatment start with atezolizumab on Cycle 1, Day 1 (cycle length=21 days). An additional two doses of obinutuzumab will be administered on Days 85 and 86 of study treatment (Cycle 5, Day 1 and Cycle 5, Day 2). | Drug | Arm E: Atezolizumab with Obinutuzumab |
| PEG-interferon alfa-2aAlso: Pegasys®Participant will receive PEG-interferon alfa-2a 180 micrograms subcutaneous injection q3w for a total of 6 cycles (Cycle = 21 days). | Drug | Arm C: Atezolizumab with PEG- interferon alfa-2a, Arm D:Atezolizumab with PEG-interferon alfa-2a and Bevacizumab |
Primary outcome
Recommended Phase II Dose (RP2D) of Atezolizumab When Given in Combination With Ipilimumab and Interferon Alfa-2b
Time frame: From the first atezolizumab treatment up to 21 days
Percentage of Participants with Adverse Events
Time frame: From the first atezolizumab treatment up to 4.5 years (yr)
15 secondary outcomes
Percentage of Participants with Best Overall Response, as Assessed Using Conventional Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Screening to progression or death, up to 4.5 yr (assessed at baseline, every 6 weeks for 48 weeks and every 12 weeks thereafter up to treatment completion/early termination [up to 4.5 yr])
Percentage of Participants with Best Overall Response, as Assessed Using Immune Modified RECIST Criteria
Time frame: Screening to progression or death, up to 4.5 years (assessed at baseline, every 6 weeks for 48 weeks and every 12 weeks thereafter up to treatment completion/early termination [up to 4.5 yr])
Duration of Objective Response
Time frame: Screening to progression or death, up to 4.5 yr (assessed at baseline, every 6 weeks for 48 weeks and every 12 weeks thereafter up to treatment completion/early termination [up to 4.5 yr])
Overall Survival
Time frame: Baseline to death (up to 4.5 yr)
Progression-Free Survival
Time frame: Screening to progression or death, up to 4.5 yr (assessed at baseline, every 6 weeks for 48 weeks and every 12 weeks thereafter up to treatment completion/early termination [up to 4.5 yr])
Percentage of Participants with Objective Response, as Assessed Using Conventional RECIST v1.1
Time frame: Screening to progression or death, up to 4.5 yr (assessed at Baseline, every 6 weeks for 48 weeks and every 12 weeks thereafter up to treatment completion/early termination [up to 4.5 yr])
Percentage of Participants with Objective Response, as Assessed Using Immune Modified RECIST Criteria
Time frame: Screening to progression or death, up to 4.5 yr (assessed at Baseline, every 6 weeks for 48 weeks and every 12 weeks thereafter up to treatment completion/early termination [up to 4.5 yr])
Serum Atezolizumab Concentration
Time frame: Baseline up to 4.5 years (detailed timeframe is given in outcome description)
Serum Ipilimumab Concentration
Time frame: Baseline up to 4.5 years (detailed timeframe is given in outcome description)
Serum Bevacizumab Concentration
Time frame: Baseline up to 4.5 years (detailed timeframe is given in outcome description)
Serum Obinutuzumab Concentration
Time frame: Baseline up to 4.5 years (detailed outcome given in outcome description)
Anti-Drug Antibody to Atezolizumab
Time frame: Baseline up to 4.5 years (detailed timeframe is given in outcome description)
Anti-Drug Antibody to Ipilimumab
Time frame: Baseline up to 4.5 years (detailed timeframe is given in outcome description)
Anti-Drug Antibody to Bevacizumab
Time frame: Baseline up to 4.5 years (detailed timeframe is given in outcome description)
Anti-Drug Antibody to Obinutuzumab
Time frame: Baseline up to 4.5 years (detailed timeframe is given in outcome description)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
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Malignant Solid Neoplasm
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
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Atezolizumab, Bevacizumab and Interferon alfa-2b in people with Solid Cancers, run by Hoffmann-La Roche at 9 sites in 2 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 24 inclusion and 41 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 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Netherlands. 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?
Recommended Phase II Dose (RP2D) of Atezolizumab When Given in Combination With Ipilimumab and Interferon Alfa-2b (time frame: From the first atezolizumab treatment up to 21 days). The study lists 2 primary outcomes in all. 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 12 May 2020.