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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-523014-84-00 | EU Trial (CTIS) Number |
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Sponsor's decision
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Randomized Period: FOLFOX or FOLFIRI + Bevacizumab + Inavolisib | Experimental | Participants will receive either FOLFOX or FOLFIRI and Bevacizumab along with Inavolisib. |
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| Randomized Period: FOLFOX or FOLFIRI + Bevacizumab + Placebo | Placebo Comparator | Participants will receive either FOLFOX or FOLFIRI and Bevacizumab along with Placebo. |
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| Safety Run-in Period: FOLFOX or FOLFIRI + Bevacizumab + Inavolisib | Experimental | Participants will receive either FOLFIRI or FOLFOX and Bevacizumab along with Inavolisib. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inavolisib | Drug | Participants will receive Inavolisib as per the schedule mentioned in the protocol. |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety Run-in Period: Percentage of Participants With Adverse Events (AEs) | Approximately 4 Years | |
| Percentage of Participants With an Objective Response Rate | The percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1.) | From Baseline Untill Radiographic Disease Progression (Approximately 4 Years) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | Time from randomization to death from any cause or the first occurrence of disease progression as determined by the investigator according to RECIST v1.1 (whichever occurs first) | From Baseline Untill Radiographic Disease Progression (up to Approximately 4 Years) |
| Randomized Phase: Overall Survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
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For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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| Bevacizumab | Drug | Participants will receive Bevacizumab as per the schedule mentioned in the protocol. |
|
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| FOLFOX | Drug | Participants will receive FOLFOX as per the schedule mentioned in the protocol. |
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| FOLFIRI | Drug | Participants will receive FOLFIRI as per the schedule mentioned in the protocol. |
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| Placebo | Drug | Participants will receive Placebo as per the schedule mentioned in the protocol. |
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Defined as the time from randomization to death from any cause |
| From Baseline Untill Death (up to Approximately 4 Years) |
| Randomized Phase: Disease Control Rate (DCR) | Defined as the percentage of participants with stable disease for >=12 weeks or a CR or PR as determined by the investigator according to RECIST v1.1 | From Baseline Untill Disease Progression (up to Approximately 4 Years) |
| Randomized Phase: Duration of Response (DOR) | Defined as the time from the first occurrence of a documented confirmed OR to death from any cause or the first occurrence of disease progression as determined by the investigator according to RECIST v1.1, (whichever occurs first) | From Baseline Untill Disease Progression or Death (up to Approximately 4 Years) |
| Randomized Phase: Percentage of Participants With AEs | From Baseline up to 90 Days After the Final Dose of study treatment or Until Initiation of Another Anti-cancer Therapy (up to Approximately 4 Years) |
| Percentage of Participants With Symptomatic Treatment Toxicities as Assessed by National Cancer Institute Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE) | Up to Approximately 4 Years |
| Percentage of Participants Troubled by Treatment Symptoms, as Assessed by Single Item European Organisation for Research and Treatment of Cancer Item Library 46 (EORTC IL46) | Up to Approximately 4 Years |
| Change From Baseline in Symptomatic Treatment Toxicities as Assessed by PRO-CTCAE | Baseline up to Approximately 4 Years |
| Change From Baseline in Treatment Side-effect Bother as Assessed by EORTC IL46 item | Baseline up to Approximately 4 Years |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| C000723546 | inavolisib |
| D000068258 | Bevacizumab |
| C410216 | Folfox protocol |
| C480833 | IFL protocol |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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