Your session is about to expire
← Back to Search
PI3Kinase Inhibition + Anti-PD-1 Antibody for Colorectal Cancer
Study Summary
This trial is testing a new combo therapy for patients with relapsed or refractory solid tumors, specifically those with mismatch-repair proficient colorectal cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 2 trial • 24 Patients • NCT02631590Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- I have been treated with a PI3K inhibitor before.I am fully active or can carry out light work.I am on medication for seizures.I have a history of bleeding problems.I've completed all treatments meant to cure me and have had at least 2 types of systemic therapy.My cancer has spread to my brain or spinal cord.My cancer can be biopsied.I am infected with HIV or hepatitis B or C.I have an autoimmune disease that needed treatment in the last year.I've had at least 2 treatments for my cancer, including specific chemotherapy drugs.I am not on anti-arrhythmic drugs, except for beta blockers or digoxin.I haven't had cancer treatment or surgery in the last 4 weeks.I have previously been treated with immunotherapy.I am currently being treated for an infection with medication.My organ and bone marrow functions meet the study's requirements.I cannot or will not follow the study's schedule.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.You have had an allergic reaction to the study drug.I've completed all treatments meant to cure me and have had at least 2 different standard treatments.I have had pneumonitis treated with steroids or have it now.I had radiotherapy less than 2 weeks ago.I have a wound, ulcer, or fracture that is not healing.I have a heart condition that is not well-managed.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.You are expected to live for more than 3 months.I have not had a blood or platelet transfusion in the week before starting treatment.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 not received a live vaccine in the last 30 days.I have a history of or currently have interstitial lung disease.I haven't taken drugs that strongly affect liver enzymes in the last 2 weeks.I am 18 years old or older.I have not taken any immunosuppressive drugs in the last 7 days.I have another cancer that is getting worse or needs treatment.
- Group 1: Phase II/Arm B -P13K wild type /Copanlisib and Nivolumab
- Group 2: Phase I - Copanlisib and Nivolumab (De-Escalation)
- Group 3: Phase II /Arm A-P13K mutation/Copanlisib and Nivolumab
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is there any precedent for the utilization of Copanlisib in clinical research?
"At present, 84 clinical trials of Copanlisib are in their final stage with 741 active studies. Most of these investigations are occurring in Basel, BE; nevertheless there are over 40 thousand medical sites running related research."
Is enrollment for this research study still open?
"According to clinicaltrials.gov, this trial is not currently open for enrollment. Initially posted on January 17th 2019 and last updated August 16th 2022, the study has yet to begin recruiting participants; however there are a plethora of other trials actively seeking volunteers at present."
What objectives does this research endeavor aim to accomplish?
"This clinical trial, estimated to take 6-months, seeks to measure the highest tolerable dose of copanlisib in conjunction with a fixed dosage of nivolumab. Secondary goals include assessing Progression Free Survival (PFS) status at 6 months, Duration of Response (DOR) over 6 months, and Overall Survival (OS) during this period as well."
Is this an unprecedented clinical investigation?
"Research into copanlisib began in 2012, with the first study sponsored by Ono Pharmaceutical Co. Ltd. and comprising 659 participants. Upon completion of Phase 1 & 2 testing, copanlisib was approved for medical use; now there are 741 trials underway across 2404 cities and 55 countries worldwide."
What conditions commonly respond to treatment with Copanlisib?
"Copanlisib is typically utilized as an anti-angiogenic agent, yet it has also been proven effective in treating a variety of other medical issues such as malignant neoplasms, unresectable melanoma, and squamous cell carcinoma."
What is the current enrolment rate for this research trial?
"This clinical trial has since ceased its recruitment process. It first opened on January 17th 2019 and was last updated on August 16th 2022. For individuals in search of other studies, there are 243 trials involving patients with malignant neoplasms actively recruiting, as well as 741 studies for Copanlisib searching for participants."
Share this study with friends
Copy Link
Messenger