A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)

Conditions

• Metastatic Colorectal Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Inavolisib — DRUG
  Inavolisib will be administered orally as per schedule specified in the respective arms.
• Bevacizumab — DRUG
  Bevacizumab IV will be administered as per schedule specified in the respective arm.
• Cetuximab — DRUG
  Cetuximab IV will be administered as per schedule specified in the respective arm.
• Atezolizumab — DRUG
  Atezolizumab IV infusion will be administered as per schedule specified in the respective arm.
• Tiragolumab — DRUG
  Tiragolumab IV infusion will be administered as per schedule specified in the respective arm.
• SY-5609 — DRUG
  SY-5609 will be administered by mouth as per schedule specified in the respective arm.
• Divarasib — DRUG
  Divarasib will be administered orally as per schedule specified in the respective arms.
• FOLFOX — DRUG
  FOLFOX (5-fluorouracil, leucovorin, oxaliplatin) IV will be administered as per schedule specified in the respective arm.
• FOLFIRI — DRUG
  FOLFIRI (leucovorin, 5-fluorouracil, irinotecan) IV will be administered as per schedule specified in the respective arm.
• FoundationOne®Liquid CDx — DIAGNOSTIC_TEST
  FoundationOne®Liquid CDx is used to identify presence of genomic alterations for participant cohort assignment.

Study Details

This open-label, exploratory study is designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or combinations, in participants with metastatic colorectal cancer (mCRC) whose tumors are biomarker positive as per treatment arm-specific definition. Eligible participants with mCRC will be enrolled into specific treatment arms based on their biomarker assay results.

Key Dates

Start date

Oct 22, 2021

Status verified

May 2026

Primary completion

Aug 31, 2030

Completion

Aug 31, 2030

Study Design

Enrollment

542 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Inavolisib + Cetuximab
  Participants will receive 9 milligrams (mg) of inavolisib by mouth once daily (QD) on Days 8-28 of Cycle 1, then QD on Days 1-28 from Cycle 2 onwards (1 cycle=28 days). Participants will also receive cetuximab intravenous (IV) infusion 400 mg/m2 body surface area on Day 1 of Cycle 1. All subsequent weekly (QW) doses will be 250 mg/m2 each. This arm is closed.
• Experimental: Inavolisib + Bevacizumab
  Participants will receive 9 mg of inavolisib by mouth QD combined with bevacizumab 15 milligram/kilogram (mg/kg) IV once every three weeks (Q3W) on Day 1 of each cycle (1 cycle=21 days). This arm is closed.
• Experimental: Atezolizumab + Tiragolumab + Bevacizumab
  Participants in this randomized cohort will receive 1200 mg of atezolizumab by IV infusion on Day 1 of each cycle, combined with tiragolumab at a dose of 600 mg IV infusion on Day 1 of each cycle and bevacizumab IV infusion at a dose of 15 mg/kg on Day 1 of each cycle. (Cycle length=21 days) This arm is active, and not recruiting participants.
• Experimental: Atezolizumab + Tiragolumab
  Participants in this randomized cohort will receive 1200 mg of atezolizumab by IV infusion on Day 1 of each cycle combined with tiragolumab 600 mg IV infusion on Day 1 of each cycle. (Cycle length=21 days) This arm is active, and not recruiting participants.
• Experimental: Atezolizumab + SY-5609
  Participants will receive 1680 mg of atezolizumab by IV infusion on Day 1 of each cycle Q4W in repeated 28-day cycles combined with SY-5609 at a dose of 3, 4, 5, 6, 7 or 10 mg by mouth for 7 days, followed by 7 days off. (Cycle length=28 days) This arm is closed.
• Experimental: Divarasib + Cetuximab + FOLFOX
  Participants will receive cetuximab IV 500 mg/m2 body surface area on Days 1 and 15 and FOLFOX on Days 1 and 15 with divarasib PO QD on Days 1-28. (Cycle length=28 days) This arm is recruiting participants.
• Experimental: Divarasib + Cetuximab
  Participants will receive cetuximab IV 500 mg/m2 body surface area on Days 1 and 15 with divarasib PO QD on Days 1-28. (Cycle length=28 days) This arm is active, and not recruiting participants.
• Experimental: Divarasib + Cetuximab + FOLFIRI
  Participants will receive cetuximab IV 500 mg/m2 body surface area on Days 1 and 15 and FOLFIRI on Days 1 and 15 with divarasib PO QD on Days 1-28. (Cycle length=28 days) This arm is active, and not recruiting participants.
• Experimental: Divarasib + Bevacizumab + FOLFOX
  Participants will receive Bevacizumab 5 mg/kg by IV infusion on Days 1 and 15 and FOLFOX on Days 1 and 15 with Divarasib PO QD on Days 1-28. (Cycle length=28 days) This arm is recruiting participants.
• Experimental: Divarasib + Bevacizumab + FOLFIRI
  Participants will receive Bevacizumab 5 mg/kg by IV infusion on Days 1 and 15 and FOLFIRI on Days 1 and 15 with Divarasib PO QD on Days 1-28. (Cycle length=28 days) This arm is recruiting participants.

Primary Outcome Measure

Objective Response Rate [ Time Frame: Approximately 84 months ]

Central Contacts

• Reference Study ID Number: WO42758 https://forpatients.roche.com/
  888-662-6728 (U.S. and Canada)
  [email protected]

Locations (35)

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