Study on Adding Copanlisib to Usual Immunotherapy for Advanced Solid Cancers with PIK3CA and PTEN Gene Changes

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT04317105

This clinical trial is testing whether adding the drug Copanlisib to standard immunotherapy treatments (Nivolumab with or without Ipilimumab) can improve outcomes for patients with advanced solid cancers that have specific genetic changes.

Patient Parameters

Parameter	Options

Program Overview

This study aims to find the best dose and assess the safety of Copanlisib when combined with immunotherapy drugs Nivolumab and Ipilimumab. It focuses on patients with advanced solid cancers that have spread and have changes in the PIK3CA and PTEN genes. Copanlisib may help stop cancer growth by blocking certain enzymes, while Nivolumab and Ipilimumab help the immune system attack cancer cells. Researchers want to see if this combination works better than immunotherapy alone.

Description

The main goal of this study is to determine the safest and most effective dose of Copanlisib when used with Nivolumab and Ipilimumab in patients with advanced solid tumors that have specific genetic changes. Researchers will also observe how well the treatment works in shrinking tumors and improving survival rates.

The study is divided into two parts:

Trial I: Patients receive Copanlisib through an IV on specific days of the first cycle. Starting in the second cycle, they also receive Nivolumab. Treatment cycles repeat every 28 days unless the disease progresses or side effects become unacceptable. Patients will have regular scans and biopsies to monitor the cancer.
Trial II: Similar to Trial I, but patients also receive Ipilimumab every 8 weeks for 4 doses. The treatment schedule and monitoring are the same as in Trial I.

After completing the treatment, patients will have follow-up visits for up to 2 years to monitor their health and any long-term effects.

Eligibility Criteria

Inclusion Criteria

Must have advanced cancer that cannot be surgically removed and does not respond to standard treatments.
Must be at least 18 years old.
Must have good overall health with specific blood counts and organ function levels.
Must not have received any cancer treatment for at least 4 weeks before starting the study.
Must have specific genetic changes in the PIK3CA or PTEN genes.
Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for several months after.
Must be willing to provide tumor samples for research.
Must understand and agree to the study requirements.

Exclusion Criteria

Cannot be participating in another clinical trial.
Cannot be pregnant or breastfeeding.
Cannot have active hepatitis B or C infections.
Cannot have uncontrolled infections or other serious illnesses.
Cannot have a history of severe allergic reactions to similar drugs.
Cannot have active autoimmune diseases requiring treatment.
Cannot have received live vaccines recently.
Cannot be taking certain medications that interact with Copanlisib.

Locations

FACILITY	ZIP	CITY	STATE
Dana-Farber Cancer Institute	02215	Boston	Massachusetts
University of Texas at Austin	78712	Austin	Texas
University of Texas Medical Branch	77555-0565	Galveston	Texas
M D Anderson Cancer Center	77030	Houston	Texas
VCU Massey Comprehensive Cancer Center	23298	Richmond	Virginia

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