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PI3K inhibitor

Copanlisib + Immunotherapy for Advanced Solid Cancers

Phase 1 & 2
Waitlist Available
Led By Timothy A Yap
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective
Patients must be >= 4 weeks beyond treatment with any chemotherapy or other investigational therapy to include hormonal, biological, or targeted agents; or at least 5 half-lives from hormonal, biological, or targeted agents, whichever is shorter at the time of treatment initiation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years post-treatment
Awards & highlights

Study Summary

This trial is testing the effects of copanlisib, given with nivolumab and ipilimumab, on patients with solid cancers that have spread and have changes in PIK3CA and PTEN genes.

Who is the study for?
Adults with advanced solid cancers and specific gene changes (PIK3CA/PTEN) can join this trial. They must have a good performance status, controlled diabetes, measurable disease by certain criteria, and no recent other treatments. Pregnant or breastfeeding women, those with active infections or CNS metastases, and individuals on strong CYP3A4 inhibitors/inducers are excluded.Check my eligibility
What is being tested?
The trial is testing the effectiveness of adding Copanlisib to standard immunotherapy (Nivolumab with/without Ipilimumab) in treating advanced solid tumors with PIK3CA and PTEN mutations. It's a phase I/II study aiming to find the best dose while monitoring how well patients respond compared to usual treatment.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation such as inflammation in various organs, infusion-related symptoms like fever or chills, blood sugar level changes due to Copanlisib's effect on cell growth enzymes, fatigue, liver enzyme alterations, and increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has spread, cannot be surgically removed, and standard treatments are not effective.
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I haven't had chemotherapy or other cancer treatments for at least 4 weeks.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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My cancer can be biopsied for Trial 1.
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I have been treated with PD-1/PD-L1/PI3K inhibitors before.
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My kidney function is within the normal range or slightly above.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events and serious adverse events
Incidence of dose limiting toxicities (DLTs)
Secondary outcome measures
Clinical benefit rate (OR + stable disease [SD] > 6 months)
Heart rate
Overall survival (OS)
+1 more
Other outcome measures
Ipilimumab
Change in tumor immune microenvironment with copanlisib alone and with combination of copanlisib, nivolumab and ipilimumab
Correlation of change in expression of pharmacodynamics markers downstream of PI3K inhibition and change in expression of genes involved in alternate signaling pathways with OR to treatment
+3 more

Side effects data

From 2017 Phase 3 trial • 1289 Patients • NCT01285609
38%
Alopecia
36%
Anaemia
32%
Nausea
31%
Decreased appetite
31%
Diarrhoea
30%
Fatigue
25%
Constipation
23%
Neutropenia
20%
Dyspnoea
19%
Vomiting
19%
Pyrexia
18%
Rash
17%
Asthenia
17%
Cough
16%
Pruritus
16%
Thrombocytopenia
16%
Arthralgia
15%
Peripheral sensory neuropathy
14%
Myalgia
13%
Insomnia
13%
Neuropathy peripheral
11%
Hypokalaemia
10%
Platelet count decreased
9%
Pain in extremity
9%
Weight decreased
9%
Leukopenia
8%
Alanine aminotransferase increased
8%
Hyponatraemia
8%
Pneumonia
8%
Haemoglobin decreased
7%
Neutrophil count decreased
7%
Dizziness
7%
Malignant neoplasm progression
7%
Aspartate aminotransferase increased
7%
Bone pain
7%
Haemoptysis
7%
Back pain
6%
Headache
6%
Hypomagnesaemia
6%
Stomatitis
5%
Abdominal pain upper
5%
Oedema peripheral
5%
White blood cell count decreased
5%
Chest pain
5%
Dehydration
5%
Abdominal pain
4%
Febrile neutropenia
4%
Paraesthesia
4%
Musculoskeletal pain
3%
Colitis
2%
Death
2%
Lung infection
2%
Pulmonary embolism
2%
Mucosal inflammation
1%
Lung neoplasm malignant
1%
Multi-organ failure
1%
Cerebrovascular accident
1%
Lung abscess
1%
General physical health deterioration
1%
Interstitial lung disease
1%
Liver function test abnormal
1%
Sudden death
1%
Chronic obstructive pulmonary disease
1%
Metastases to central nervous system
1%
Blood creatinine increased
1%
Atrial fibrillation
1%
Cardio-respiratory arrest
1%
Confusional state
1%
Intestinal perforation
1%
Pulmonary haemorrhage
1%
Drug hypersensitivity
1%
Infection
1%
Pneumothorax
1%
Renal failure
1%
Lower respiratory tract infection
1%
Pain
1%
Respiratory failure
1%
Syncope
1%
Hyperglycaemia
1%
Sepsis
1%
Acute kidney injury
1%
Hypersensitivity
1%
Urinary tract infection
1%
Disease progression
1%
Pneumonitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
10 MG/KG Ipilimumab + Paclitaxel/ Carbop
Placebo + Paclitaxel/ Carboplatin

Trial Design

2Treatment groups
Experimental Treatment
Group I: Trial II (copanlisib, nivolumab, ipilimumab)Experimental Treatment8 Interventions
Patients receive copanlisib hydrochloride IV over 1 hour on days 1, 8, and 15 of cycle 1. Beginning in cycle 2, patients also receive nivolumab IV over 60 minutes on day 1 and ipilimumab IV over 90 minutes every 8 weeks for 4 doses. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo an x-ray and/or CT scan during screening and every 8 weeks, as well as a tumor biopsy at baseline, cycle 1 day 15, cycle 2 day 15, and every 3 weeks thereafter, and at disease progression. Patients also undergo blood sample collection at baseline, cycle 1 days 8 and 15, cycle 2 day 15, cycle 4 day 1 and disease progression. Patients undergo ECHO during screening and as clinically indicated on study.
Group II: Trial I (copanlisib, nivolumab)Experimental Treatment7 Interventions
Patients receive copanlisib hydrochloride IV over 1 hour on days 1, 8, and 15 of cycle 1. Beginning in cycle 2, patients also receive nivolumab IV over 60 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo an x-ray and/or CT scan during screening and every 8 weeks, as well as a tumor biopsy at baseline, cycle 1 day 15, cycle 2 day 15, and every 3 weeks thereafter, and at disease progression. Patients also undergo blood sample collection at baseline, cycle 1 days 8 and 15, cycle 2 day 15, cycle 4 day 1 and disease progression. Patients undergo ECHO during screening and as clinically indicated on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Echocardiography
2013
Completed Phase 4
~11670
Biopsy
2014
Completed Phase 4
~850
Biospecimen Collection
2004
Completed Phase 2
~1730
Computed Tomography
2017
Completed Phase 2
~2720
Ipilimumab
2014
Completed Phase 3
~2670
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,051 Total Patients Enrolled
Timothy A YapPrincipal InvestigatorUniversity of Texas MD Anderson Cancer Center LAO
9 Previous Clinical Trials
434 Total Patients Enrolled

Media Library

Copanlisib Hydrochloride (PI3K inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04317105 — Phase 1 & 2
Cancer Research Study Groups: Trial I (copanlisib, nivolumab), Trial II (copanlisib, nivolumab, ipilimumab)
Cancer Clinical Trial 2023: Copanlisib Hydrochloride Highlights & Side Effects. Trial Name: NCT04317105 — Phase 1 & 2
Copanlisib Hydrochloride (PI3K inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04317105 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment open for this experiment at present?

"As indicated on clinicaltrials.gov, this medical trial is still recruiting patients. It was originally posted in April 2020 and its last update was made on September 2022."

Answered by AI

Could you please detail the past experiments conducted with Ipilimumab?

"A decade ago, ipilimumab was initially trialled at Texas Children's Hospital. Over the course of these 10 years, 383 experiments have been completed and there are now 788 live trials in progress - many being conducted from Richmond, Virginia."

Answered by AI

What is the geographic distribution of this investigation?

"At present, this trial has 5 active sites throughout the United States and Canada. These include Virginia Commonwealth University/Massey Cancer Center in Richmond, University Health Network-Princess Margaret Hospital in Toronto, and University of Texas Medical Branch in Galveston. Additionally there are 2 more hospitals participating as well."

Answered by AI

How is ipilimumab typically administered in therapeutic settings?

"Ipilimumab is a common remedy for cutaneous melanoma and has been used to fight off other diseases such as anti-angiogenic therapy, malignant neoplasms, and unresectable melanoma."

Answered by AI

How many participants have enrolled in this clinical trial?

"Affirmative. Clinicaltrials.gov reveals that the medicinal trial was first advertised on April 15th 2020, and is still recruiting participants as of September 15th 2022--102 subjects at 5 distinct locations to be precise."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Testing the Addition of an Anti-cancer Drug, Copanlisib, to the Usual Immunotherapy (Nivolumab With or Without Ipilimumab) in Patients With Advanced Solid Cancers That Have Changes in the Following Genes: PIK3CA and PTEN
2020. "Testing the Addition of an Anti-cancer Drug, Copanlisib, to the Usual Immunotherapy (Nivolumab With or Without Ipilimumab) in Patients With Advanced Solid Cancers That Have Changes in the Following Genes: PIK3CA and PTEN". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04317105.
~15 spots leftby Dec 2024
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