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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Avelumab — DRUG
  Given IV
• Biopsy Procedure — PROCEDURE
  Undergo biopsy of tumor
• Biospecimen Collection — PROCEDURE
  Undergo collection of blood samples
• Computed Tomography — PROCEDURE
  Undergo CT scan
• Hypofractionated Radiation Therapy — RADIATION
  Undergo hypofractionated RT
• Peposertib — DRUG
  Given PO

Study Details

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.

Key Dates

Start date

Apr 7, 2020

Status verified

Feb 2026

Primary completion

Jul 1, 2027

Completion

Jul 1, 2027

Study Design

Enrollment

103 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm A (hypofractionated RT, avelumab)
  Patients undergo 8 fractions of hypofractionated RT QD on days -17 to -7. Patients also receive avelumab IV over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo biopsy, CT, and collection of blood on the trial.
• Experimental: Arm B (hypofractionated RT, peposertib, avelumab)
  Patients undergo 8 fractions of hypofractionated RT QD on days -17 to -7. Patients also receive peposertib PO BID on days 1-28, and avelumab IV over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo biopsy, CT, and collection of blood on the trial.
• Experimental: Phase I (hypofractionated RT, peposertib, avelumab)
  Patients with advanced/metastatic malignant solid tumors undergo 8 fractions of hypofractionated RT QD on days -17 to -7. Patients also receive peposertib PO BID on days 1-28, and avelumab IV over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, biopsy, and collection of blood samples during screening and on study.

Primary Outcome Measure

Maximum tolerated doses and recommended phase 2 dose of peposertib (M3814) in combination with hypofractionated radiation and avelumab (Phase 1) [ Time Frame: Up to 28 days ]

Locations (46)

Find similar trials in Duarte, CA

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