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PI3K Inhibitor
PI3Kinase Inhibition + Anti-PD-1 Antibody for Colorectal Cancer
Phase 1 & 2
Waitlist Available
Led By Nilofer Azad, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Phase I: Must have received all curative treatment options and at least 2 lines of systemic therapy
Must not have
Prior therapy with a PI3K inhibitor
Seizure disorder requiring anti-seizure medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
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.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects include reactions related to the immune system attacking normal cells leading to inflammation in various organs (like lungs), potential blood sugar changes due to Copanlisib's effect on insulin regulation, fatigue from Nivolumab affecting energy levels, as well as general risks associated with infusion therapies.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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I've completed all treatments meant to cure me and have had at least 2 types of systemic therapy.
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My cancer can be biopsied.
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I've had at least 2 treatments for my cancer, including specific chemotherapy drugs.
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I've completed all treatments meant to cure me and have had at least 2 different standard treatments.
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I will use an approved method of birth control during the study.
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I am not pregnant and will follow the study's birth control requirements.
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I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been treated with a PI3K inhibitor before.
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I am on medication for seizures.
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I have a history of bleeding problems.
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My cancer has spread to my brain or spinal cord.
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I am infected with HIV or hepatitis B or C.
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I have previously been treated with immunotherapy.
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I am currently being treated for an infection with medication.
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I have not had any blood clots in the last 3 months.
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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.
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I have had pneumonitis treated with steroids or have it now.
Select...
I have a wound, ulcer, or fracture that is not healing.
Select...
I have a heart condition that is not well-managed.
Select...
I have had fluid removed from my abdomen recently or have swelling causing discomfort.
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I have diabetes and am treated with specific medications or insulin.
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I have a history of or currently have interstitial lung disease.
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I have not taken any immunosuppressive drugs in the last 7 days.
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I have another cancer that is getting worse or needs treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
6-month Objective Response Rate (ORR) of Patients Treated With Copanlisib and Nivolumab
Number of Participants Experiencing a Dose Limiting Toxicity
Secondary study objectives
Disease Control Rate (DCR) Status at 6 Months.
Duration of Response (DOR)
Number of Participants Experiencing Study Drug-related Toxicities
+2 moreSide effects data
From 2021 Phase 2 trial • 24 Patients • NCT0263159075%
Platelet count decreased
75%
Lymphocyte count decreased
71%
Fatigue
71%
White blood cell decreased
67%
Anemia
67%
Neutrophil count decreased
63%
Hypertension
54%
Hyperglycemia
50%
Nausea
46%
Anorexia
46%
Diarrhea
46%
Lipase increased
42%
Alanine aminotransferase increased
42%
Abdominal Pain
33%
Fever
29%
Hyponatremia
25%
Hyperkalemia
25%
Dehydration
25%
Hypotension
25%
Weight loss
25%
Vomiting
25%
Constipation
25%
Rash maculo-papular
21%
Serum amylase increased
21%
Aspartate aminotransferase increased
21%
Edema limbs
17%
Chills
17%
Thromboembolic event
17%
Pain
17%
Alkaline phosphatase increased
17%
Creatinine increased
17%
Sinus tachycardia
17%
Dizziness
13%
Dyspnea
13%
Generalized muscle weakness
13%
Pain in extremity
13%
Hypoalbuminemia
13%
Blood bilirubin increased
13%
Infusion related reaction
13%
Non-cardiac chest pain
13%
Gastrointestinal disorders - Other
13%
Mucositis oral
13%
Sepsis
13%
Upper respiratory infection
13%
Urinary tract infection
13%
Anxiety
13%
Tinnitus
8%
Back pain
8%
Pleural effusion
8%
Neck pain
8%
Insomnia
8%
Gallbladder obstruction
8%
Hypoxia
8%
Ascites
8%
Cough
8%
Bloating
8%
General disorders and administration site conditions -Other
8%
Abdominal distension
8%
Dysphagia
8%
Pruritus
8%
Rash acneiform
8%
Peripheral sensory neuropathy
8%
Infections and infestations - Other
8%
Dysgeusia
8%
Depression
4%
Phlebitis
4%
Postnasal drip
4%
Acute kidney injury
4%
Stomach pain
4%
Blood antidiuretic hormone abnormal
4%
Urine output decreased
4%
Bone pain
4%
Allergic reaction
4%
Hiccups
4%
Sore throat
4%
Paroxysmal atrial tachycardia
4%
Hypercalcemia
4%
Hoarseness
4%
Pericarditis
4%
Confusion
4%
Neoplasms benign, malignant and unspecified - Other
4%
Ear pain
4%
Dry eye
4%
Injury, poisoning and procedural complications - Other
4%
Gait disturbance
4%
Atelectasis
4%
Colonic obstruction
4%
Investigations - Other
4%
Hyperuricemia
4%
Epistaxis
4%
Pneumonitis
4%
Cholecystitis
4%
Gastrointestinal disorders -Other
4%
Pancreatitis
4%
Hypernatremia
4%
Hypomagnesemia
4%
Aspiration
4%
Colitis
4%
Dry mouth
4%
Infusion site extravasation
4%
Toothache
4%
Activated partial thromboplastin time prolonged
4%
Hypokalemia
4%
Nasal congestion
4%
Productive cough
4%
Wheezing
4%
Fracture
4%
Venous injury
4%
Cataract
4%
Hepatic infection
4%
Infections and Infestations - Other
4%
Urinary tract obstruction
4%
Lung infection
4%
Gastroesophageal reflux disease
4%
Malaise
4%
Musculoskeletal and connective tissue disorders - Other
4%
Skin ulceration
4%
Headache
4%
Parathesia
4%
Gallbladder infection
4%
Dry skin
4%
Skin and subcutaneous tissue disorders - Other
4%
Sinus bradycardia
4%
Cystitis noninfective
4%
Hematuria
4%
Renal and urinary disorders - Other
4%
Urine discoloration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Combination Therapy
Trial Design
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Copanlisib
2016
Completed Phase 2
~130
Nivolumab
2014
Completed Phase 3
~5220
Find a Location
Who is running the clinical trial?
BayerIndustry Sponsor
2,260 Previous Clinical Trials
25,309,397 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,678 Previous Clinical Trials
4,125,597 Total Patients Enrolled
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
566 Previous Clinical Trials
33,328 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- 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
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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