Atezolizumab
DrugParticipant will receive atezolizumab 600 milligrams (mg) or 1200 mg by IV infusion q3w.
Other names: Tecentriq, RO5541267, MPDL3280A
NCT Number: NCT02174172
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).
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 1
The Netherlands Cancer Institute of Amsterdam, Amsterdam, Netherlands
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Inclusion criteria
specific to Arm A: Atezolizumab+ Ipilimumab
Inclusion criteria
specific to Arm B: Atezolizumab+ Interferon alfa-2b
Inclusion criteria
Specific to Arm C (Atezolizumab plus PEG-Interferon Alafa-2a):
Inclusion criteria
Specific to Arm D (Atezolizumab plus PEG-Interferon Alfa-2a +Bevacizumab)
Inclusion criteria
Specific to Arm E (Atezolizumab +Obinutuzumab)
Inclusion criteria
Specific to prior Anti-PD-L1/PD-1 Treated Cohorts:
Exclusion criteria
General Medical Exclusions:
Cancer-Specific Exclusions:
Exclusion criteria
Related to Medications:
Exclusion criteria
Specific to Interferon Alpha Therapy (Arms B-D):
Exclusion criteria
Specific to Bevacizumab (Arm D)
Exclusion criteria
Specific Obinutuzumab (Arm E)
Participant will receive atezolizumab 600 milligrams (mg) or 1200 mg by IV infusion q3w.
Other names: Tecentriq, RO5541267, MPDL3280A
Participant will receive Bevacizumab 15 milligrams per kilograms (mg/kg) IV infusion q3w.
Other names: Avastin®
Participants will receive Interferon alfa-2b 3, 5, or 10 million international units subcutaneously every other day for up to 3 doses per week.
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).
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).
Participant will receive PEG-interferon alfa-2a 180 micrograms subcutaneous injection q3w for a total of 6 cycles (Cycle = 21 days).
Other names: Pegasys®
Time frame: From the first atezolizumab treatment up to 21 days
Time frame: From the first atezolizumab treatment up to 4.5 years (yr)
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])
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])
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])
Time frame: Baseline to death (up to 4.5 yr)
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])
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])
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])
Time frame: Baseline up to 4.5 years (detailed timeframe is given in outcome description)
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)
Time frame: Baseline up to 4.5 years (detailed timeframe is given in outcome description)
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
Time frame: Baseline up to 4.5 years (detailed timeframe is given in outcome description)
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
Time frame: Baseline up to 4.5 years (detailed outcome given in outcome description)
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
Time frame: Baseline up to 4.5 years (detailed timeframe is given in outcome description)
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)
Time frame: Baseline up to 4.5 years (detailed timeframe is given in outcome description)
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
Time frame: Baseline up to 4.5 years (detailed timeframe is given in outcome description)
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
Time frame: Baseline up to 4.5 years (detailed timeframe is given in outcome description)
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
Hoffmann-La Roche
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05396300
Colonic Diseases, Colorectal Cancer
Hangzhou, Zhejiang, China
View Trial DetailsNCT00909740
Neoplasms, Solid Cancers
View Trial DetailsNCT02323191
Solid Cancers
New Haven, Connecticut, United States
View Trial DetailsNCT01820299
Solid Cancers
Charleston, South Carolina, United States
View Trial Details