CI

At a glance

ClinicalIndex Comparison Record
Phase 1Active· 39 enrolled / 39 target
Drug / intervention
Copanlisib Hydrochloride +8 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03842228
NCT03842228Phase 1ActiveUpdate Overdue (0.5/mo)Completion was 23mo ago

A Phase 1b Biomarker-Driven Combination Trial of Copanlisib, Olaparib, and Durvalumab (MEDI4736) in Patients With Advanced Solid Tumors

National Cancer Institute (NCI)·interventional·Posted Feb 15, 2019·Updated Jun 17, 2026

In Brief

A Phase 1 clinical trial evaluating Biopsy Procedure, Biospecimen Collection, and 7 other interventions for Advanced Malignant Solid Neoplasm and 2 related conditions. Active but no longer recruiting, targeting 39 participants across 17 sites.

Signals

Enrollment appears stalled

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1Active
201920202021202220232024202520262027
First PostedFeb 15, 2019
Enrollment StartNov 21, 2019
Primary CompletionJul 29, 2024
Study CompletionDec 31, 2026
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 7.4 years ago

Arms & Interventions

Treatment (copanlisib hydrochloride, olaparib, and durvalumab)experimental

See Detailed Description

Procedure: Biopsy ProcedureProcedure: Biospecimen CollectionProcedure: Computed TomographyDrug: Copanlisib HydrochlorideBiological: DurvalumabProcedure: Echocardiography TestProcedure: Magnetic Resonance ImagingDrug: OlaparibProcedure: X-Ray Imaging

Interventions

Biopsy Procedureprocedure

Undergo tumor biopsy

Biospecimen Collectionprocedure

Undergo collection of blood samples

Computed Tomographyprocedure

Undergo CT

Copanlisib Hydrochloridedrug

Given IV

Durvalumabbiological

Given IV

Echocardiography Testprocedure

Undergo ECHO

Magnetic Resonance Imagingprocedure

Undergo MRI

Olaparibdrug

Given PO

X-Ray Imagingprocedure

Undergo x-ray