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RECRUITING Phase 1

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

NCT06496568 · View on ClinicalTrials.gov ↗

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 Studied

Interventions

  • DRUG Pembrolizumab
  • DRUG Atezolizumab
  • DRUG Inavolisib

Study Locations (8)

California

  • Moores Cancer Center at UC San Diego Health — La Jolla
  • California Cancer Associates for Research & Excellence, Inc. — San Marcos

Other

  • Seoul National University Hospital — Seoul
  • Samsung Medical Center — Seoul

Tennessee

  • Vanderbilt-Ingram Cancer Ctr — Nashville

British Columbia

  • BC Cancer Vancouver Centre — Vancouver

Ontario

  • Princess Margaret Cancer Center — Toronto

Quebec

  • Jewish General Hospital — Montreal

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2023-12-11
Est. Completion 2028-09-28
Phase Phase 1

Sponsor

Hoffmann-La Roche

758 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06496568

The ClinicalTrials.gov registry entry for NCT06496568 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with PIK3CA-Mutated Cancers appearing as the primary indexed condition, and to 3 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06496568 reports 8 study locations spanning 6 distinct geographic areas — top geographies include California, Other, Tennessee. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06496568 about?

NCT06496568 is a clinical study titled "A Study Evaluating Single-agent Inavolisib, Inavolisib Plus Atezolizumab, and Inavolisib Plus Pembrolizumab in PIK3CA-Mutated Cancers". 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, includi...

What is the current status of trial NCT06496568?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2023-12-11. Estimated completion is 2028-09-28.

What conditions does trial NCT06496568 study?

This clinical trial studies the following conditions: PIK3CA-Mutated Cancers. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06496568?

The interventions under investigation include: Pembrolizumab (DRUG), Atezolizumab (DRUG), Inavolisib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06496568?

This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06496568 being conducted?

This trial has 8 study locations across California, Tennessee, British Columbia, Ontario, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial