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

Conditions

• Solid Cancers

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Atezolizumab — DRUG
  Participant will receive atezolizumab 600 milligrams (mg) or 1200 mg by IV infusion q3w.
• Bevacizumab — DRUG
  Participant will receive Bevacizumab 15 milligrams per kilograms (mg/kg) IV infusion q3w.
• Interferon alfa-2b — DRUG
  Participants will receive Interferon alfa-2b 3, 5, or 10 million international units subcutaneously every other day for up to 3 doses per week.
• Ipilimumab — DRUG
  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 — DRUG
  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-2a — DRUG
  Participant will receive PEG-interferon alfa-2a 180 micrograms subcutaneous injection q3w for a total of 6 cycles (Cycle = 21 days).

Study Details

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).

Key Dates

Start date

Aug 18, 2014

Status verified

May 2020

Primary completion

Nov 25, 2019

Completion

Nov 25, 2019

Study Design

Enrollment

158 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A: Atezolizumab with Ipilimumab
  Participants will receive atezolizumab along with ipilimumab.
• Experimental: Arm B: Atezolizumab with Interferon alfa-2b
  Participants will receive atezolizumab along with Interferon alfa-2b.
• Experimental: Arm C: Atezolizumab with PEG- interferon alfa-2a
  Participants will receive atezolizumab along with PEG- interferon alfa-2a.
• Experimental: Arm D:Atezolizumab with PEG-interferon alfa-2a and Bevacizumab
  Participants will receive atezolizumab along with PEG- interferon alfa-2a and bevacizumab.
• Experimental: Arm E: Atezolizumab with Obinutuzumab
  Participants will receive atezolizumab along with obinutuzumab or atezolizumab alone.

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 ]

Locations (8)

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