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A Study Evaluating Single-agent Inavolisib, Inavolisib Plus Atezolizumab, and Inavolisib Plus Pembrolizumab in PIK3CA-Mutated Cancers

NCT06496568 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-12

No results posted yet for this study

Summary

The purpose of the study is to assess the safety and efficacy of inavolisib as a single-agent, in combination with atezolizumab, and in combination with pembrolizumab in participants with phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit alpha isoform (PIK3CA)-mutated cancers, including previously treated head and neck squamous cell carcinoma (HNSCC).

Conditions

  • PIK3CA-Mutated Cancers

Interventions

DRUG

Inavolisib

Participants will receive inavolisib, 9 milligram (mg), PO, QD on Days 1-21 of each 21-day cycle.

DRUG

Atezolizumab

Participants will receive atezolizumab, 1200 mg, as IV infusion Q3W on Day 1 of each 21-day cycle.

DRUG

Pembrolizumab

Participants will receive pembrolizumab as an IV infusion Q3W on Day 1 of each 21-day cycle.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-11
Primary Completion
2028-09-28
Completion
2028-09-28
FDA Drug
Yes

Countries

  • United States
  • Canada
  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06496568 on ClinicalTrials.gov