Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03842228 · ClinicalTrials.gov registry record · Phase 1
Testing the Combination of the Anti-cancer Drugs Copanlisib, Olaparib, and MEDI4736 (Durvalumab) in Patients With Advanced Solid Tumors With Selected Mutations
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
- 39
- Enrollment target
- 17
- Study locations
NCT03842228: Active Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm, sponsored by National Cancer Institute (NCI).
NCT03842228 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 39 participants, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (78% lower). The trial reports 17 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03842228, 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
- 39 participants
- Enrollment target
- 17
- Study locations
Study Summary
This phase Ib trial seeks to identify the side effects and best dose of the combination of copanlisib and olaparib when given together with durvalumab. The trial will evaluate how well the drug combinations work in treating patients with advanced cancers who have solid tumors that have spread from where they first started (primary site) to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Copanlisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as olaparib, can keep PARP from working, so tumor cells can't repair themselves and may stop growing. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The treatment combinations of copanlisib and olaparib or copanlisib, olaparib, and durvalumab may work better in treating patients with solid tumors compared to usual treatments such as surgery, radiation, or other chemotherapy drugs.
Primary Outcome
A DLT was evaluated according to the NCI CTCAE 5.0. An AE was defined as DLT if it met any of the following events: any grade 5 toxicity; any grade 2 toxicity that require permanent discontinuation of durvalumab or combination therapies within the first 4 weeks; grade 4 neutropenia; febrile neutropenia; neutropenic infection; grade ≥ 3 thrombocytopenia with bleeding; grade 4 thrombocytopenia; Grade 4 anemia; non-hematological grade ≥ 4 toxicities; confirmation of QTc prolongation; grade ≥3 AE hy
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy Procedure
- BIOLOGICAL Durvalumab
- DRUG Copanlisib Hydrochloride
Study Locations (17)
California
- Keck Medicine of USC Buena Park - Buena Park
- Keck Medicine of USC Koreatown - Los Angeles
- Los Angeles General Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- USC Norris Oncology/Hematology-Newport Beach - Newport Beach
- Keck Medical Center of USC Pasadena - Pasadena
Texas
- University of Texas at Austin - Austin
- University of Texas Medical Branch - Galveston
- M D Anderson Cancer Center - Houston
- University of Texas Health Science Center at San Antonio - San Antonio
Massachusetts
- Brigham and Women's Hospital - Boston
- Beth Israel Deaconess Medical Center - Boston
- Dana-Farber Cancer Institute - Boston
Colorado
- UCHealth University of Colorado Hospital - Aurora
Illinois
- Northwestern University - Chicago
Pennsylvania
- University of Pittsburgh Cancer Institute (UPCI) - Pittsburgh
Wisconsin
- University of Wisconsin Carbone Cancer Center - University Hospital - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2019-11-21 |
| Est. Completion | 2026-09-24 |
| Phase | Phase 1 |
What the registry record for NCT03842228 still lists
NCT03842228 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (78% lower).
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.
NCT03842228 lists 17 locations in 7 states (California, Texas, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT03842228 about?
NCT03842228 is a clinical study titled "Testing the Combination of the Anti-cancer Drugs Copanlisib, Olaparib, and MEDI4736 (Durvalumab) in Patients With Advanced Solid Tumors With Selected Mutations". This phase Ib trial seeks to identify the side effects and best dose of the combination of copanlisib and olaparib when given together with durvalumab. The trial will evaluate how well the drug combinations work in treating patients with advanced cancers who have solid tumors that have spread from w...
What is the current status of trial NCT03842228?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2019-11-21. Estimated completion is 2026-09-24.
What conditions does trial NCT03842228 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 NCT03842228?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy Procedure (PROCEDURE), Durvalumab (BIOLOGICAL), Copanlisib Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT03842228?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03842228 being conducted?
This trial has 17 study locations across California, Colorado, Illinois, Massachusetts, Pennsylvania. 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.
Where NCT03842228's enrollment target sits among peer trials
39 65th of 108 higher than 44 of 108 other Advanced Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Malignant Solid Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03465592 · 39 participants · Phase 1
Trial of Nivolumab Following Partially Human Leukocyte Antigen (HLA) Mismatched BMT in Children & Adults With Sarcoma
- NCT03961776 · 39 participants
Monitoring Treatment Response With On-board DWI During Neo-adjuvant Chemo-radiation for Rectal Cancer Using Magnetic Resonance-guided-radiotherapy Systems
- NCT04050280 · 39 participants · Phase 2
CLAG-GO for Patients With Persistent, Relapsed or Refractory AML
- NCT04190862 · 39 participants · Phase 1
E-CEL UVEC as an Adjunct Cell Therapy for Treatment of Anal Fistulas
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI