PI3Kinase Inhibition + Anti-PD-1 Antibody for Colorectal Cancer

Palo Alto (17 mi)

Overseen byNilofer Azad, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?A phase I/II study of PI3Kinase inhibition (copanlisib) and anti-PD-1 antibody nivolumab in relapsed/refractory solid tumors with expansions in mismatch-repair proficient (MSS) colorectal cancer.

Eligibility Criteria

Adults over 18 with advanced solid tumors, including colorectal cancer that's still growing despite treatment. They must have tried at least two other treatments and be in good physical shape (able to perform daily activities). Participants need functioning organs, measurable disease for tracking progress, and the ability to provide consent. Pregnant or breastfeeding women can't join, nor can those with recent serious health issues like heart attacks or infections.

Inclusion Criteria

I am fully active or can carry out light work.

I've completed all treatments meant to cure me and have had at least 2 types of systemic therapy.

My cancer can be biopsied.

I've had at least 2 treatments for my cancer, including specific chemotherapy drugs.

I've completed all treatments meant to cure me and have had at least 2 different standard treatments.

I will use an approved method of birth control during the study.

I am not pregnant and will follow the study's birth control requirements.

I am 18 years old or older.

Exclusion Criteria

I have been treated with a PI3K inhibitor before.

I am on medication for seizures.

I have a history of bleeding problems.

My cancer has spread to my brain or spinal cord.

I am infected with HIV or hepatitis B or C.

I have previously been treated with immunotherapy.

I am currently being treated for an infection with medication.

I have not had any blood clots in the last 3 months.

I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

I have had pneumonitis treated with steroids or have it now.

I have a wound, ulcer, or fracture that is not healing.

I have a heart condition that is not well-managed.

I have had fluid removed from my abdomen recently or have swelling causing discomfort.

I have diabetes and am treated with specific medications or insulin.

I have a history of or currently have interstitial lung disease.

I have not taken any immunosuppressive drugs in the last 7 days.

I have another cancer that is getting worse or needs treatment.

Treatment Details

The trial is testing Copanlisib, a PI3Kinase inhibitor, alongside Nivolumab, an anti-PD-1 antibody. It aims to see how well they work together in patients whose colorectal cancer hasn't responded to standard treatments. The study will monitor safety and effectiveness of this combination therapy.

3Treatment groups

Experimental Treatment

Group I: Phase II/Arm B -P13K wild type /Copanlisib and NivolumabExperimental Treatment2 Interventions

Group II: Phase II /Arm A-P13K mutation/Copanlisib and NivolumabExperimental Treatment2 Interventions

Group III: Phase I - Copanlisib and Nivolumab (De-Escalation)Experimental Treatment2 Interventions