WithdrawnPhase 2
A Study to Evaluate the Efficacy and Safety of Inavolisib When Administered in Combination With Bevacizumab and FOLFOX or FOLFIRI as First Line Therapy in Participants With Colorectal Cancer
Key facts
- Who runs it
- Hoffmann-La Roche
- Trial code
- Status
- Withdrawn
- Phase
- Phase 2
- Started
- 1 Feb 2026
- Expected to end
- 31 Mar 2031
- Type of study
- Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Inavolisib
- Bevacizumab
- FOLFOX
- FOLFIRI
- Placebo
- Record updated
- 9 February 2026
- Why it stopped
- Sponsor's decision
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- Eastern Cooperative Oncology Group (ECOG) <=1
- Histologically confirmed adenocarcinoma originating in the colon or rectum of the Stage 4 ( treatment plan does not include resection or curative ablation) per American Joint Committee on Cancer (AJCC) v8
- Measurable disease per RECIST v1.1
- No prior systemic therapy in the metastatic setting
- Confirmation of biomarker eligibility: documentation of a PIK3CA mutation from either central testing of tissue, or from a validated historically obtained (pre-existing) test of tumor tissue or blood may be used to confirm eligibility
- Adequate hematologic and organ function within 14 days prior to initiation of study treatment
- Agreement to adhere to the contraception requirements
Who cannot take part
- Residual Grade 2 or higher neuropathy due to prior oxaliplatin exposure (unless the participant is planned to be treated with FOLFIRI)
- History of gastrointestinal (GI) fistula, GI perforation, or intra-abdominal abscess within 6 months prior to Day 1 of Cycle 1
- Treatment with strong cytochrome P450 (CYP) 3A4 inducers or strong CYP3A4 inhibitors within 1 week or 5 drug-elimination half-lives, whichever is longer, prior to initiation of study treatment (only for patients who will receive FOLFIRI)
- Type 2 diabetes requiring ongoing systemic treatment at the time of study entry or any history of Type 1 diabetes
- Known HIV positive status with exceptions for well controlled and on stable treatment
- History of malignancy within 5 years prior to screening, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death
- Biomarker eligibility as per definition
- Symptomatic, untreated, or actively progressing CNS metastases
About the trial
What the trial wants to find out
This is a blinded Phase 2 study designed to evaluate the safety and efficacy of inavolisib with bevacizumab and chemotherapy, in participants with metastatic colorectal cancer (mCRC) whose tumors have a PIK3CA mutation. The study has a safety run-in period followed by a randomized period.
The 3 groups in the trial
- Randomized Period: FOLFOX or FOLFIRI + Bevacizumab + InavolisibTreatment being tested
Participants will receive either FOLFOX or FOLFIRI and Bevacizumab along with Inavolisib.
Treatment: Inavolisib, Bevacizumab, FOLFOX, and FOLFIRI
- Randomized Period: FOLFOX or FOLFIRI + Bevacizumab + PlaceboPlacebo, for comparison
Participants will receive either FOLFOX or FOLFIRI and Bevacizumab along with Placebo.
Treatment: Bevacizumab, FOLFOX, FOLFIRI, and Placebo
- Safety Run-in Period: FOLFOX or FOLFIRI + Bevacizumab + InavolisibTreatment being tested
Participants will receive either FOLFIRI or FOLFOX and Bevacizumab along with Inavolisib.
Treatment: Inavolisib, Bevacizumab, FOLFOX, and FOLFIRI
Data and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib With Bevacizumab Plus Folfox or Folfiri as First Line Therapy in Patients With PIK3CA-Mutated Metastatic Colorectal Cancer
- Record updated
- 9 February 2026