Testing the Combination of the Anti-cancer Drugs Copanlisib, Olaparib, and MEDI4736 (Durvalumab) in Patients With Advanced Solid Tumors With Selected Mutations

Part of paid clinical trials in Buena Park, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT03842228
Phase
PHASE1
Status
Active Not Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo tumor biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Copanlisib Hydrochloride — DRUG
    Given IV
  • Durvalumab — BIOLOGICAL
    Given IV
  • Echocardiography Test — PROCEDURE
    Undergo ECHO
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Olaparib — DRUG
    Given PO
  • X-Ray Imaging — PROCEDURE
    Undergo x-ray

Study Details

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.

Key Dates

Start date
Nov 21, 2019
Status verified
Mar 2026
Primary completion
Jul 29, 2024
Completion
Dec 31, 2026

Study Design

Enrollment
39 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (copanlisib hydrochloride, olaparib, and durvalumab)
    See Detailed Description

Primary Outcome Measure

Number of Patients With Dose Limiting Toxicities (DLT) as a Measure of Safety Profile to Determine Recommended Phase 2 Dose (RP2D) [ Time Frame: The DLT monitoring time frame was Cycle 1 through Cycle 2 Day 1 for the doublet combination (SIL1, SIL2, SIL3, and SIL3A) , and Cycle 1 through Cycle 3 Day 1 for the triplet combination (S2L1) ]

Locations (17)

FacilityCityStateZIPSite coordinators
Keck Medicine of USC Buena ParkBuena ParkCalifornia90621-
Keck Medicine of USC KoreatownLos AngelesCalifornia90020-
Los Angeles General Medical CenterLos AngelesCalifornia90033-
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
USC Norris Oncology/Hematology-Newport BeachNewport BeachCalifornia92663-
Keck Medical Center of USC PasadenaPasadenaCalifornia91105-
UCHealth University of Colorado HospitalAuroraColorado80045-
Northwestern UniversityChicagoIllinois60611-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Brigham and Women's HospitalBostonMassachusetts02115-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232-
University of Texas at AustinAustinTexas78712-
University of Texas Medical BranchGalvestonTexas77555-0565-
M D Anderson Cancer CenterHoustonTexas77030-
University of Texas Health Science Center at San AntonioSan AntonioTexas78229-
University of Wisconsin Carbone Cancer Center - University HospitalMadisonWisconsin53792-

Find similar trials in Buena Park, CA

By research site
Keck Medicine of USC Buena Park· Buena Park, CAKeck Medicine of USC Koreatown· Los Angeles, CALos Angeles General Medical Center· Los Angeles, CAUSC / Norris Comprehensive Cancer Center· Los Angeles, CAUSC Norris Oncology/Hematology-Newport Beach· Newport Beach, CAKeck Medical Center of USC Pasadena· Pasadena, CA

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