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Safety and Pharmacokinetics (PK) of Escalating Doses of MTIG7192A as a Single Agent and in Combination With Atezolizumab With and Without Chemotherapy in Locally Advanced or Metastatic Tumors

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ClinicalTrials.gov Identifier: NCT02794571
Recruitment Status : Recruiting
First Posted : June 9, 2016
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Tracking Information
First Submitted Date  ICMJE June 6, 2016
First Posted Date  ICMJE June 9, 2016
Last Update Posted Date June 30, 2020
Actual Study Start Date  ICMJE May 23, 2016
Estimated Primary Completion Date November 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2020)
  • Percentage of Participants with Dose-Limiting Toxicities (DLTs) [ Time Frame: From Baseline to the end of Cycle 1 (up to 21 days) ]
  • Percentage of Participants with Adverse Events (AEs) Graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0 [ Time Frame: From Baseline up to 90 days after last dose of study treatment or until initiation of another systemic anti-cancer therapy (up to approximately 8 years) ]
  • Number of Cycles with MTIG7192A [ Time Frame: From Baseline to last dose (up to approximately 8 years) ]
  • Phase Ia and Ib: Percentage of Participants with Anti-Drug Antibodies (ADAs) to MTIG7192A [ Time Frame: Day 1 up to 8 years ]
    Phase (Ph) 1a: Pre-dose on Day 1, Cycles 1-4, 8, 16, every eight cycles (Q8C), at discontinuation (DC), every 30 days up to 120 days; Phase 1b without Chemotherapy: Pre-dose on Day 1, Cycles 1-4, 8, then Q8C, DC (Cycle length 21 days); Phase 1b (Chemotherapy Cohorts and Q4W): Pre-dose on Day 1, Cycles 1-4, 8, 12 and 16, then DC (Cycle length 21/28 days).
  • Phase Ib: Percentage of Participants with ADAs to Atezolizumab [ Time Frame: Day 1 up to 8 years ]
    Phase 1b (without Chemotherapy): Pre-dose on Day 1, Cycles 1-4, 8, then Q8C, at DC, every 30 days up to 120 days (Cycle length 21 days); Phase 1b (Chemotherapy Cohorts and Q4W): Pre-dose on Day 1, Cycles 1-4, 8, 12 and 16, then DC (Cycle length 21/28 days).
Original Primary Outcome Measures  ICMJE
 (submitted: June 6, 2016)
  • Percentage of Participants with Dose-Limiting Toxicities (DLTs) [ Time Frame: From Baseline to the end of Cycle 1 (up to 21 days) ]
  • Percentage of Participants with Adverse Events (AEs) Graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0 [ Time Frame: From Baseline up to 90 days after last dose of study treatment or until initiation of another systemic anti-cancer therapy (up to approximately 3 years) ]
  • Number of Cycles with MTIG7192A [ Time Frame: From Baseline to last dose (up to approximately 3 years) ]
  • Dosage in Milligrams (mg) of MTIG7192A [ Time Frame: From Baseline to last dose (up to approximately 3 years) ]
  • Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) to MTIG7192A [ Time Frame: From Baseline to last ATA measurement; drawn pre-dose (0 hours [h]) Day 1 of Cycles 1-4, 8 (cycle = 21 days); then every eight cycles (Q8C) until/at discontinuation (DC) (up to 3 years); every 30 days thereafter up to 120 days (up to 3 years overall) ]
  • Percentage of Participants with ATAs to Atezolizumab [ Time Frame: From Baseline to last ATA measurement; drawn pre-dose (0 h) Day 1 of Cycles 1-4, 8 (cycle = 21 days); then Q8C until/at DC (up to 3 years); every 30 days thereafter up to 120 days (up to 3 years overall) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2020)
  • Area Under the Concentration-Time Curve (AUC) of MTIG7192A [ Time Frame: Day 1 up to 8 years ]
    During Phase Ia and Phase Ib dose-escalation stages time frame is as follows: Pre-dose Day 1,Cycles 1-4, 8; Cycle 1: Post-dose-0.5 hour (h), 24 h, Days 8 and 15; Day 1, Cycles 2-7 (Ph 1a), Cycles 2, 3, 4 ,8, 16 -0.5 h post-dose; ph1a and 1b - Q8C, DC; every 30 days up to 120 days. During Phase Ia dose-expansion stage and Phase Ib dose-expansion stages with and without chemotherapy time frame is as follows: Pre-dose Day 1,Cycles 1-4, 8; Cycle 1: Post-dose-0.5 hour (h), 24 h, Days 8 and 15; Day 1, Cycles 2, 3, 4, 8, 12* 16 (C12* only applicable to Q4W and Chemotherapy cohorts): 0.5 h post-dose; ph1a and 1b (Q3W)- Q8C, DC; every 30 days up to 120 days.
  • Maximum Serum Concentration (Cmax) of MTIG7192A [ Time Frame: Day 1 up to 8 years ]
    During Phase Ia and Phase Ib dose-escalation stages time frame is as follows: Pre-dose Day 1,Cycles 1-4, 8; Cycle 1: Post-dose-0.5 hour (h), 24 h, Days 8 and 15; Day 1, Cycles 2-7 (Ph 1a), Cycles 2, 3, 4 ,8, 16 -0.5 h post-dose; ph1a and 1b - Q8C, DC; every 30 days up to 120 days. During Phase Ia dose-expansion stage and Phase Ib dose-expansion stages with and without chemotherapy time frame is as follows: Pre-dose Day 1,Cycles 1-4, 8; Cycle 1: Post-dose-0.5 hour (h), 24 h, Days 8 and 15; Day 1, Cycles 2, 3, 4, 8, 12* 16 (C12* only applicable to Q4W and Chemotherapy cohorts): 0.5 h post-dose; ph1a and 1b (Q3W)- Q8C, DC; every 30 days up to 120 days.
  • Minimum Serum Concentration (Cmin) of MTIG7192A [ Time Frame: Day 1 up to 8 years ]
    During Phase Ia and Phase Ib dose-escalation stages time frame is as follows: Pre-dose Day 1,Cycles 1-4, 8; Cycle 1: Post-dose-0.5 hour (h), 24 h, Days 8 and 15; Day 1, Cycles 2-7 (Ph 1a), Cycles 2, 3, 4 ,8, 16 -0.5 h post-dose; ph1a and 1b - Q8C, DC; every 30 days up to 120 days. During Phase Ia dose-expansion stage and Phase Ib dose-expansion stages with and without chemotherapy time frame is as follows: Pre-dose Day 1,Cycles 1-4, 8; Cycle 1: Post-dose-0.5 hour (h), 24 h, Days 8 and 15; Day 1, Cycles 2, 3, 4, 8, 12* 16 (C12* only applicable to Q4W and Chemotherapy cohorts): 0.5 h post-dose; ph1a and 1b (Q3W)- Q8C, DC; every 30 days up to 120 days.
  • Clearance (CL) of MTIG7192A [ Time Frame: Day 1 up to 8 years ]
    During Phase Ia and Phase Ib dose-escalation stages time frame is as follows: Pre-dose Day 1,Cycles 1-4, 8; Cycle 1: Post-dose-0.5 hour (h), 24 h, Days 8 and 15; Day 1, Cycles 2-7 (Ph 1a), Cycles 2, 3, 4 ,8, 16 -0.5 h post-dose; ph1a and 1b - Q8C, DC; every 30 days up to 120 days. During Phase Ia dose-expansion stage and Phase Ib dose-expansion stages with and without chemotherapy time frame is as follows: Pre-dose Day 1,Cycles 1-4, 8; Cycle 1: Post-dose-0.5 hour (h), 24 h, Days 8 and 15; Day 1, Cycles 2, 3, 4, 8, 12* 16 (C12* only applicable to Q4W and Chemotherapy cohorts): 0.5 h post-dose; ph1a and 1b (Q3W)- Q8C, DC; every 30 days up to 120 days.
  • Volume of Distribution at Steady State (Vss) of MTIG7192A [ Time Frame: Day 1 up to 8 years ]
    During Phase Ia and Phase Ib dose-escalation stages time frame is as follows: Pre-dose Day 1,Cycles 1-4, 8; Cycle 1: Post-dose-0.5 hour (h), 24 h, Days 8 and 15; Day 1, Cycles 2-7 (Ph 1a), Cycles 2, 3, 4 ,8, 16 -0.5 h post-dose; ph1a and 1b - Q8C, DC; every 30 days up to 120 days. During Phase Ia dose-expansion stage and Phase Ib dose-expansion stages with and without chemotherapy time frame is as follows: Pre-dose Day 1,Cycles 1-4, 8; Cycle 1: Post-dose-0.5 hour (h), 24 h, Days 8 and 15; Day 1, Cycles 2, 3, 4, 8, 12* 16 (C12* only applicable to Q4W and Chemotherapy cohorts): 0.5 h post-dose; ph1a and 1b (Q3W)- Q8C, DC; every 30 days up to 120 days.
  • Cmax of Atezolizumab [ Time Frame: Day 1 up to 8 years ]
    During Phase Ib dose-escalation stage time frame will be as follows: Pre-dose Day 1,Cycles 1-4, 8; Cycle 1: Post-dose-0.5 hour (h), 24 h, Days 8 and 15; Day 1, Cycles 2 ,3, 4, 8, 16: 0.5 h post-dose; Q8C, DC; every 30 days up to 120 days. During Phase Ib dose-expansion stages time frame will be as follows: Pre-dose on Day 1 of Cycles 1-4,8, 12*, 16 (C12* only applicable to Q4W and Chemotherapy cohorts); Post-dose (0.5 h or 24h), on Day 1 of Cycles 1-4, 8, 12, 16; then Q8C until/at DC, every 30 days up to 120 days.
  • Cmin of Atezolizumab [ Time Frame: Day 1 up to 8 years ]
    During Phase Ib dose-escalation stage time frame will be as follows: Pre-dose Day 1,Cycles 1-4, 8; Cycle 1: Post-dose-0.5 hour (h), 24 h, Days 8 and 15; Day 1, Cycles 2 ,3, 4, 8, 16: 0.5 h post-dose; Q8C, DC; every 30 days up to 120 days. During Phase Ib dose-expansion stages time frame will be as follows: Pre-dose on Day 1 of Cycles 1-4,8, 12*, 16 (C12* only applicable to Q4W and Chemotherapy cohorts); Post-dose (0.5 h or 24h), on Day 1 of Cycles 1-4, 8, 12, 16; then Q8C until/at DC, every 30 days up to 120 days.
  • Plasma Concentration of Cisplatin [ Time Frame: Pre-dose (5 min) and post-dose (1 h) on Day 1 of Cycles 1 and 3 ]
  • Plasma Concentration of Carboplatin [ Time Frame: Pre-dose (5 min) and post-dose (1 h) on Day 1 of Cycles 1 and 3 ]
  • Plasma Concentration of Pemetrexed [ Time Frame: Pre-dose (5 min) and post-dose (1 h) on Day 1 of Cycles 1 and 3 ]
  • Plasma Concentration of Paclitaxel [ Time Frame: Pre-dose (5 min) and post-dose (1 h) on Day 1 of Cycles 1 and 3 ]
  • Plasma Concentration of Etoposide [ Time Frame: Pre-dose (5 min) and post-dose (1 h) on Day 1 of Cycles 1 and 3 ]
  • Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [ Time Frame: From Baseline until disease progression (up to 8 years) ]
  • Duration of Objective Response (DOR) According to RECIST Version 1.1 [ Time Frame: From Baseline until disease progression (up to 8 years) ]
  • Progression-Free Survival (PFS) According to RECIST Version 1.1 [ Time Frame: From Baseline until disease progression (up to 8 years) ]
  • Overall survival (OS) According to RECIST Version 1.1 [ Time Frame: Baseline until death from any cause (up to approximately 8 years) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2016)
  • Area Under the Concentration-Time Curve (AUC) of MTIG7192A during Phase Ia Dose-Escalation Stage [ Time Frame: Post-dose (0.5 h) Day 1 of Cycles 1-7 (cycle = 21 days); post-dose (24 h) Day 2 of Cycle 1; on Days 8, 15 of Cycle 1; pre-dose (0 h) Day 1 of Cycles 1-8; then Q8C until/at DC (up to 3 years); every 30 days up to 120 days (up to 3 years overall) ]
  • AUC of MTIG7192A during Phase Ia Expansion Stage and Phase Ib Stages [ Time Frame: Post-dose (0.5 h) Day 1 of Cycles 1-4 (cycle = 21 days); post-dose (24 h) Day 2 of Cycle 1; on Days 8, 15 of Cycle 1; pre-dose (0 h) Day 1 of Cycles 1-4, 8; then Q8C until/at DC (up to 3 years); every 30 days up to 120 days (up to 3 years overall) ]
  • Maximum Serum Concentration (Cmax) of MTIG7192A during Phase Ia Dose-Escalation Stage [ Time Frame: Post-dose (0.5 h) Day 1 of Cycles 1-7 (cycle = 21 days); post-dose (24 h) Day 2 of Cycle 1; on Days 8, 15 of Cycle 1; pre-dose (0 h) Day 1 of Cycles 1-8; then Q8C until/at DC (up to 3 years); every 30 days up to 120 days (up to 3 years overall) ]
  • Cmax of MTIG7192A during Phase Ia Expansion Stage and Phase Ib Stages [ Time Frame: Post-dose (0.5 h) Day 1 of Cycles 1-4 (cycle = 21 days); post-dose (24 h) Day 2 of Cycle 1; on Days 8, 15 of Cycle 1; pre-dose (0 h) Day 1 of Cycles 1-4, 8; then Q8C until/at DC (up to 3 years); every 30 days up to 120 days (up to 3 years overall) ]
  • Minimum Serum Concentration (Cmin) of MTIG7192A during Phase Ia Dose-Escalation Stage [ Time Frame: Pre-dose (0 h) Day 1 of Cycles 1-8; then Q8C until/at DC (up to 3 years); every 30 days up to 120 days (up to 3 years overall) ]
  • Cmin of MTIG7192A during Phase Ia Expansion Stage and Phase Ib Stages [ Time Frame: Pre-dose (0 h) Day 1 of Cycles 1-4, 8; then Q8C until/at DC (up to 3 years); every 30 days up to 120 days (up to 3 years overall) ]
  • Clearance (CL) of MTIG7192A during Phase Ia Dose-Escalation Stage [ Time Frame: Post-dose (0.5 h) Day 1 of Cycles 1-7 (cycle = 21 days); post-dose (24 h) Day 2 of Cycle 1; on Days 8, 15 of Cycle 1; pre-dose (0 h) Day 1 of Cycles 1-8; then Q8C until/at DC (up to 3 years); every 30 days up to 120 days (up to 3 years overall) ]
  • CL of MTIG7192A during Phase Ia Expansion Stage and Phase Ib Stages [ Time Frame: Post-dose (0.5 h) Day 1 of Cycles 1-4 (cycle = 21 days); post-dose (24 h) Day 2 of Cycle 1; on Days 8, 15 of Cycle 1; pre-dose (0 h) Day 1 of Cycles 1-4, 8; then Q8C until/at DC (up to 3 years); every 30 days up to 120 days (up to 3 years overall) ]
  • Volume of Distribution at Steady State (Vss) of MTIG7192A during Phase Ia Dose-Escalation Stage [ Time Frame: Post-dose (0.5 h) Day 1 of Cycles 1-7 (cycle = 21 days); post-dose (24 h) Day 2 of Cycle 1; on Days 8, 15 of Cycle 1; pre-dose (0 h) Day 1 of Cycles 1-8; then Q8C until/at DC (up to 3 years); every 30 days up to 120 days (up to 3 years overall) ]
  • Vss of MTIG7192A during Phase Ia Expansion Stage and Phase Ib Stages [ Time Frame: Post-dose (0.5 h) Day 1 of Cycles 1-4 (cycle = 21 days); post-dose (24 h) Day 2 of Cycle 1; on Days 8, 15 of Cycle 1; pre-dose (0 h) Day 1 of Cycles 1-4, 8; then Q8C until/at DC (up to 3 years); every 30 days up to 120 days (up to 3 years overall) ]
  • Progression-Free Survival (PFS) According to RECIST Version 1.1 [ Time Frame: From Baseline until disease progression (up to 3 years) ]
  • Cmax of Atezolizumab during Phase Ib Dose-Escalation Stage [ Time Frame: Post-dose (0.5 h) Day 1 of Cycles 1-4 (cycle = 21 days); on Days 8, 15 of Cycle 1; pre-dose (0 h) Day 1 of Cycles 1-4, 8; then Q8C until/at DC (up to 3 years); every 30 days up to 120 days (up to 3 years overall) ]
  • Cmax of Atezolizumab during Phase Ib Expansion Stage [ Time Frame: Post-dose (0.5 h) Day 1 of Cycles 1, 4 (cycle = 21 days); on Days 8, 15 of Cycle 1; pre-dose (0 h) Day 1 of Cycles 1-4, 8; then Q8C until/at DC (up to 3 years); every 30 days up to 120 days (up to 3 years overall) ]
  • Cmin of Atezolizumab during Phase Ib Stages [ Time Frame: Pre-dose (0 h) Day 1 of Cycles 1-4, 8; then Q8C until/at DC (up to 3 years); every 30 days up to 120 days (up to 3 years overall) ]
  • Percentage of Participants with Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [ Time Frame: From Baseline until disease progression (up to 3 years) ]
  • Duration of Objective Response (DOR) According to RECIST Version 1.1 [ Time Frame: From Baseline until disease progression (up to 3 years) ]
  • Maximum Tolerated Dose (MTD) in mg of MTIG7192A as a Single Agent and in Combination with Atezolizumab [ Time Frame: From Baseline to the end of Cycle 1 (up to 21 days) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Pharmacokinetics (PK) of Escalating Doses of MTIG7192A as a Single Agent and in Combination With Atezolizumab With and Without Chemotherapy in Locally Advanced or Metastatic Tumors
Official Title  ICMJE A Phase Ia/Ib Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of MTIG7192A as a Single Agent and in Combination With Atezolizumab Administered With and Without Chemotherapy in Patients With Locally Advanced or Metastatic Tumors
Brief Summary This first-in-human open-label, multicenter, dose-escalation and expansion study is designed to evaluate the safety, tolerability, and PK of MTIG7192A alone or in combination with atezolizumab administered with and without chemotherapy in participants with locally advanced, recurrent, or metastatic incurable tumors for whom standard therapy does not exist, has proven to be ineffective or intolerable, or is considered inappropriate, or for whom a clinical trial of an investigational agent is a recognized standard of care.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced/Metastatic Tumors
Intervention  ICMJE
  • Drug: Atezolizumab
    Atezolizumab will be given as 1200 mg via IV infusion on Day 1 of each 21-day cycle (phase Ib dose-escalation, Q3W dose-expansion and chemotherapy dose-expansion cohorts) and atezolizumab at dose 1680 mg IV will be administered on Day 1 of each 28-day cycle (phase Ib Q4W dose-expansion).
    Other Names:
    • MPDL3280A
    • Tecentriq
  • Drug: MTIG7192A
    Several dose levels will be evaluated for MTIG7192A administered as a single agent and in combination with atezolizumab with and without chemotherapy. MTIG7192A will be given via intravenous (IV) infusion on Day 1 of each cycle (21-day cycle for phase Ia and Ib dose escalation, phase Ia dose-expansion, phase Ib Q3W dose-expansion and phase 1b chemotherapy dose-expansion cohorts; and 28-day cycle for phase Ib Q4W dose-expansion) until disease progression or loss of clinical benefit. Those who discontinue treatment with single-agent MTIG7192A may receive combination treatment with MTIG7192A and atezolizumab with and without chemotherapy. Combination treatment may continue until disease progression or loss of clinical benefit.
    Other Names:
    • RO7092284
    • tiragolumab
  • Drug: Carboplatin
    Carboplatin, AUC of 6 milligram per milliliter per minute (mg/ml/min) for Cohorts A and B and AUC of 5 mg/ml/min for Cohort C, IV infusion will be administered on Day 1 of each 21-day cycle after combination treatment of atezolizumab and MTIG7192A IV infusion.
  • Drug: Cisplatin
    Cisplatin 75 milligram per square meter (mg/m^2) IV infusion will be administered on day 1 of each 21-day cycle after combination treatment of atezolizumab and MTIG7192A
  • Drug: Pemetrexed
    Pemetrexed 500 mg/m^2 IV infusion will be administered on Day 1 of each 21-day cycle after carboplatin or cisplatin IV infusion with combination treatment of atezolizumab and MTIG7192.
  • Drug: Paclitaxel
    Paclitaxel 200 mg/m^2 IV infusion on Day 1 of each 21-day cycle after combination treatment with atezolizumab and MTIG7192A.
  • Drug: Etoposide
    Etoposide 100 mg/m^2 IV infusion on Days 1, 2, 3 Q3W in 21-day cycle with combination treatment of atezolizumab and MTIG7192.
Study Arms  ICMJE
  • Experimental: Phase Ia Dose-Escalation Stage: MTIG7192A
    Cohorts of at least 3 participants each will be treated with escalating doses of MTIG7192A.
    Intervention: Drug: MTIG7192A
  • Experimental: Phase Ia Dose-Expansion Stage: MTIG7192A+Atezolizumab
    Participants will be treated with MTIG7192A at or below the maximum tolerated dose (MTD) or maximum administered dose (MAD) in the study.
    Intervention: Drug: MTIG7192A
  • Experimental: Phase Ib Q3W Dose-Escalation Stage: MTIG7192A+Atezolizumab
    A minimum of 3 participants will be treated for each dose level of MTIG7192A in combination with a fixed dose of atezolizumab.
    Interventions:
    • Drug: Atezolizumab
    • Drug: MTIG7192A
  • Experimental: Phase Ib Q3W Dose-Expansion Stage: MTIG7192A+Atezolizumab
    Participants will be treated every 3 weeks (Q3W) with MTIG7192A at or below the MTD or MAD in combination with a fixed dose of atezolizumab.
    Interventions:
    • Drug: Atezolizumab
    • Drug: MTIG7192A
  • Experimental: Phase Ib Chemotherapy Dose-Expansion Stage: Cohort A
    In Cohort A, carboplatin or cisplatin and pemetrexed chemotherapy will be administered after atezolizumab and MTIG7192A IV infusion. During induction phase, participants will receive atezolizumab and MTIG7192A in combination with carboplatin or cisplatin and pemetrexed on Day 1 of each 21-day cycle for 4 to 6 cycles. During maintenance phase, participants will receive atezolizumab and MTIG7192A in combination with pemetrexed on Day 1 of each 21-day cycle.
    Interventions:
    • Drug: Atezolizumab
    • Drug: MTIG7192A
    • Drug: Carboplatin
    • Drug: Cisplatin
    • Drug: Pemetrexed
  • Experimental: Phase Ib Chemotherapy Dose-Expansion Stage: Cohort B
    In Cohort B, carboplatin and paclitaxel chemotherapy will be administered after atezolizumab and MTIG7192A IV infusion. During induction phase, participants will receive atezolizumab and MTIG7192A in combination with carboplatin and paclitaxel on Day 1 of each 21-day cycle for 4 to 6 cycles. During maintenance phase, participants will receive atezolizumab and MTIG7192A on Day 1 of each 21-day cycle.
    Interventions:
    • Drug: Atezolizumab
    • Drug: MTIG7192A
    • Drug: Carboplatin
    • Drug: Paclitaxel
  • Experimental: Phase Ib Chemotherapy Dose-Expansion Stage: Cohort C
    In Cohort C, carboplatin or cisplatin and etoposide chemotherapy will be administered after atezolizumab and MTIG7192A IV infusion. During induction phase, participants will receive atezolizumab and MTIG7192A in combination with carboplatin or cisplatin on Day 1 of each 21-day cycle and etoposide on Day 1 to 3 of each 21-day cycle for 4 cycles. During maintenance phase, participants will receive atezolizumab and MTIG7192A on Day 1 of each 21-day cycle.
    Interventions:
    • Drug: Atezolizumab
    • Drug: MTIG7192A
    • Drug: Carboplatin
    • Drug: Cisplatin
    • Drug: Etoposide
  • Experimental: Phase Ib Q4W Dose-Expansion Stage: MTIG7192A + Atezolizumab
    Participants will be treated every 4 weeks (Q4W) with fixed doses of MTIG7192A and atezolizumab.
    Interventions:
    • Drug: Atezolizumab
    • Drug: MTIG7192A
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 25, 2020)
400
Original Estimated Enrollment  ICMJE
 (submitted: June 6, 2016)
300
Estimated Study Completion Date  ICMJE November 1, 2022
Estimated Primary Completion Date November 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adults 18 years of age or older
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy at least 12 weeks
  • Adequate hematologic and end organ function
  • Histologic documentation of locally advanced, recurrent, or metastatic incurable malignancy that has progressed after at least one available standard therapy; or for which standard therapy has proven ineffective, intolerable, or considered inappropriate; or for which a clinical trial of an investigational agent is a recognized standard of care
  • Confirmed availability of representative tumor specimens
  • Measurable disease according to RECIST Version 1.1

Exclusion Criteria:

  • Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to initiation of study treatment
  • Malignancies other than disease under study within 5 years prior to Day 1 of Cycle 1
  • Primary central nervous system (CNS) malignancy, or untreated/active CNS metastases
  • Leptomeningeal disease
  • History of idiopathic pulmonary fibrosis, pneumonitis, organizing pneumonia, or evidence of active pneumonitis on Screening chest computed tomograph (CT) scan
  • History of autoimmune disease
  • Positive human immunodeficiency virus (HIV) test
  • Active hepatitis B or C, or tuberculosis
  • Severe infection within 4 weeks prior to randomization
  • Prior allogeneic bone marrow or solid organ transplant
  • Significant cardiovascular disease
  • Known clinically significant liver disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Reference Study ID Number: GO30103 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com
Listed Location Countries  ICMJE Australia,   Canada,   France,   Korea, Republic of,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02794571
Other Study ID Numbers  ICMJE GO30103
2016-000944-33 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Genentech, Inc.
Study Sponsor  ICMJE Genentech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Genentech, Inc.
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP