Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04317105 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
- 6
- Study locations
NCT04317105 is a Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 54 participants, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (69% lower). The trial reports 6 study locations across 4 states.
The verdict
NCT04317105, a Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
- 6
- Study locations
Study Summary
This phase I/II trial studies the side effects and best dose of copanlisib when given together with nivolumab and ipilimumab and to see how well they work in treating patients with solid cancers that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and have changes in PIK3CA and PTEN genes. Copanlisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The addition of copanlisib to usual immunotherapy may work better in treating patients with solid cancers compared to usual immunotherapy alone.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy Procedure
- PROCEDURE Echocardiography Test
- DRUG Copanlisib Hydrochloride
Study Locations (6)
Texas
- University of Texas at Austin - Austin
- University of Texas Medical Branch - Galveston
- M D Anderson Cancer Center - Houston
Massachusetts
- Dana-Farber Cancer Institute - Boston
Virginia
- VCU Massey Comprehensive Cancer Center - Richmond
Ontario
- University Health Network-Princess Margaret Hospital - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2020-07-17 |
| Est. Completion | 2026-12-17 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04317105
The ClinicalTrials.gov registry entry for NCT04317105 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (69% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Advanced Malignant Solid Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT04317105 reports 6 study locations spanning 4 distinct geographic areas - top geographies include Texas, Massachusetts, Virginia.
Frequently Asked Questions
What is clinical trial NCT04317105 about?
NCT04317105 is a clinical study titled "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". This phase I/II trial studies the side effects and best dose of copanlisib when given together with nivolumab and ipilimumab and to see how well they work in treating patients with solid cancers that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the b...
What is the current status of trial NCT04317105?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2020-07-17. Estimated completion is 2026-12-17.
What conditions does trial NCT04317105 study?
This clinical trial studies the following conditions: Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Unresectable Malignant Solid Neoplasm.
What interventions are being tested in trial NCT04317105?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy Procedure (PROCEDURE), Echocardiography Test (PROCEDURE), Copanlisib Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT04317105?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04317105 being conducted?
This trial has 6 study locations across Massachusetts, Texas, Virginia, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Advanced Malignant Solid Neoplasm
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors
RECRUITING · Phase 1
-
Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors
RECRUITING · Phase 1
-
Phase I/II Randomized Study of NBTXR3 Activated by Abscopal or RadScopal Radiation in Combination With Immunotherapy (Anti-PD-1/L-1) for Patients With Advanced Solid Malignancies
RECRUITING · Phase 1
-
The Immune Effects of Fermented Wheat Germ Nutritional Supplementation in Patients With Advanced Solid Tumor Cancers Being Treated With Standard of Care Checkpoint Inhibitors
RECRUITING · Phase 1
-
Studying TAK-243 in Patients With Advanced Cancer
RECRUITING · Phase 1
-
Testing How the Body Responds to the Drug CBX-12 in Patients With Advanced Solid Cancers
RECRUITING · Phase 1
Explore more on PlainTrial
Advanced Malignant Solid Neoplasm
All registered trials for this condition
Metastatic Malignant Solid Neoplasm
All registered trials for this condition
Massachusetts
All trials with a study site in Massachusetts
Recruiting now
Find trials open to new participants near you
Rankings
Top sponsors, conditions, and phases
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.