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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 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.

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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.

Conditions Studied

Advanced Malignant Solid Neoplasm Metastatic Malignant Solid Neoplasm Unresectable Malignant Solid Neoplasm

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

FieldValue
Enrollment Target 39 participants
Start Date 2019-11-21
Est. Completion 2026-09-24
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

3,257 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03842228

The ClinicalTrials.gov registry entry for NCT03842228 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 39 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 (78% 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.

NCT03842228 reports 17 study locations spanning 7 distinct geographic areas - top geographies include 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.

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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.