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Checkpoint Inhibitor

Peposertib + Avelumab + Radiation for Hepatobiliary Cancer

Phase 1 & 2
Recruiting
Led By Kristen R Spencer
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ability to swallow and retain oral medication
Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights

Study Summary

This trial is testing peposertib, in combination with avelumab and hypofractionated radiation therapy, as a potential new treatment for patients with solid tumors and hepatobiliary malignancies.

Who is the study for?
Adults with advanced/metastatic solid tumors or hepatobiliary malignancies, who have tried standard treatments without success or declined them. They must be in relatively good health (ECOG <=2), have measurable cancer lesions, and agree to biopsies if needed. Pregnant women, those with certain psychiatric illnesses, uncontrolled diseases, recent live vaccinations, or on strong immune system drugs can't join.Check my eligibility
What is being tested?
The trial is testing Peposertib combined with Avelumab and hypofractionated radiation therapy against advanced cancers. It aims to find the best dose of Peposertib and see how well it works alongside an immunotherapy drug (Avelumab) and a type of intense short-term radiation treatment.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system attacking normal cells as well as typical chemotherapy effects like fatigue, digestive issues, skin reactions from radiation therapy. Specific organ inflammation such as pneumonitis may occur due to either medication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can swallow and keep down pills.
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I can take care of myself but may not be able to do heavy physical work.
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I have an advanced tumor that has not responded to or cannot be treated by standard therapies.
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My cancer is advanced, cannot be surgically removed, and has not responded to or cannot be treated with standard therapies.
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I am not pregnant.
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My cancer has spread or can't be removed, and I've tried or can't try standard treatments.
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I have a tumor or lymph node that can be measured and hasn't been treated with radiation.
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I am 18 years old or older.
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I can take care of myself but might not be able to do active work.
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I have at least one tumor that can be targeted for radiation to ease symptoms.
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My kidney function is normal or only slightly below normal.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated doses and recommended phase 2 dose of peposertib (M3814) in combination with hypofractionated radiation and avelumab (Phase I)
Objective response rate (ORR) (Phase 2)
Secondary outcome measures
Defects in deoxyribonucleic acid (DNA) damage repair
Differential response to therapy (Phase 2)
Disease control rate (DCR) (Phase 2)
+7 more
Other outcome measures
Circulating T lymphocyte quantification and characterization
Defects in DNA damage repair
Differential response to therapy
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm B (hypofractionated RT, peposertib, avelumab)Experimental Treatment5 Interventions
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.
Group II: Arm A (hypofractionated RT, avelumab)Active Control5 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hypofractionated Radiation Therapy
2016
Completed Phase 3
~130
Biospecimen Collection
2004
Completed Phase 2
~1720
Computed Tomography
2017
Completed Phase 2
~2720
Peposertib
2021
Completed Phase 1
~20
Avelumab
2018
Completed Phase 2
~2450

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,719 Previous Clinical Trials
40,963,457 Total Patients Enrolled
Kristen R SpencerPrincipal InvestigatorLaura and Isaac Perlmutter Cancer Center at NYU
1 Previous Clinical Trials
105 Total Patients Enrolled
~11 spots leftby Dec 2024
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