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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%)

Must not have

Serious active infection within 4 weeks prior to enrollment

Uncontrolled intercurrent illness

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had a serious infection in the last 4 weeks.

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I do not have any uncontrolled illnesses.

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I have received immunotherapy before.

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I have chronic hepatitis B or C with an active infection.

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I have had a solid organ or bone marrow transplant in the past.

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I haven't had cancer treatment or been part of a study in the last 3 weeks.

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I haven't taken any immune-weakening drugs in the last 6 weeks.

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I am allergic to medications similar to M3814 or avelumab.

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I have not received a live vaccine in the last 30 days.

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I am taking more than 10 mg of prednisone daily for an autoimmune disease.

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I have had lung conditions like pulmonary fibrosis or pneumonia.

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I am taking sorivudine or similar drugs and cannot stop before starting M3814 and avelumab.

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I still have side effects from cancer treatment, but only hair loss is not a concern.

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I cannot stop taking my acid reflux medication before starting the trial drugs.

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I cannot stop taking certain medications that affect how drugs are processed in my body.

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I have untreated brain or spinal cord disease.

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I have HIV with an unstable treatment plan or a low CD4 count.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Defects in deoxyribonucleic acid (DNA) damage repair

Differential response to therapy (Phase 2)

Disease control rate (DCR) (Phase 2)

+7 more

Other study objectives

Circulating T lymphocyte quantification and characterization

Defects in DNA damage repair

Differential response to therapy

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Computed Tomography

2017

Completed Phase 2

~2790