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Testing the Combination of New Anti-cancer Drug Peposertib With Avelumab and Radiation Therapy for Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies

NCT04068194 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2026-05-13

No results posted yet for this study

Summary

This phase I/II trial studies the best dose and side effects of peposertib and to see how well it works with avelumab and hypofractionated radiation therapy in treating patients with solid tumors and hepatobiliary malignancies that have spread to other places in the body (advanced/metastatic). Peposertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Giving peposertib in combination with avelumab and hypofractionated radiation therapy may work better than other standard chemotherapy, hormonal, targeted, or immunotherapy medicines available in treating patients with solid tumors and hepatobiliary malignancies.

Conditions

  • Locally Advanced Malignant Solid Neoplasm
  • Locally Advanced Unresectable Cholangiocarcinoma
  • Locally Advanced Unresectable Gallbladder Carcinoma
  • Locally Advanced Unresectable Malignant Solid Neoplasm
  • Metastatic Cholangiocarcinoma
  • Metastatic Gallbladder Carcinoma
  • Metastatic Malignant Solid Neoplasm
  • Stage III Gallbladder Cancer AJCC v8
  • Stage IV Gallbladder Cancer AJCC v8
  • Unresectable Malignant Solid Neoplasm

Interventions

DRUG

Avelumab

Given IV

PROCEDURE

Biopsy Procedure

Undergo biopsy of tumor

PROCEDURE

Biospecimen Collection

Undergo collection of blood samples

PROCEDURE

Computed Tomography

Undergo CT scan

RADIATION

Hypofractionated Radiation Therapy

Undergo hypofractionated RT

DRUG

Peposertib

Given PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Kristen R Spencer · Laura and Isaac Perlmutter Cancer Center at NYU

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-07
Primary Completion
2027-07-01
Completion
2027-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04068194 on ClinicalTrials.gov