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Checkpoint Inhibitor

Peposertib + Avelumab + Radiation for Hepatobiliary Cancer

Q: How many locations can potential participants access this research project?

This medical research is actively enrolling from 4 distinct trial sites. Besides Richmond, New Brunswick and Chicago, there are other locations that can be found with ease. To reduce the amount of travelling required, it might be beneficial to pick a nearby clinic if you decide to join this clinical trial.

Q: Is there still an opportunity for participants to join this clinical trial?

Affirmative, the information on clinicaltrials.gov attests that this medical trial is presently recruiting participants. It was published to the site on December 23rd 2019 and has been modified as recently as October 15th 2022; 39 individuals are required from four locations.

Q: Is this a pioneering clinical trial?

As of now, 115 active clinical trials on Peposertib are occurring across 1024 cities and 52 nations. The inaugural trial for the drug commenced in 2014 with EMD Serono Research &#x26; Development Institute as its sponsor; 204 patients participated in this Phase 2 study which was concluded successfully. In the years since then, 130 studies have been completed.

Q: How many participants are included in this medical experiment?

This trial necessitates 39 qualified individuals to join the research. Participants can be sourced from different medical facilities, with two primary locations being <a href="https://www.withpower.com/clinical-trials/virginia">Virginia</a> Commonwealth University/Massey <a href="https://www.withpower.com/clinical-trials/cancer">Cancer</a> Center in Richmond and Rutgers Cancer Institute of <a href="https://www.withpower.com/clinical-trials/new-jersey">New jersey</a> in New Brunswick.

Q: Has there been any previous research into the efficacy of Peposertib?

Currently, there are 115 medical studies focused on Peposertib; 10 of these active trials are at the Phase 3 stage. Though most locations for these experiments lie in Houston, <a href="https://www.withpower.com/clinical-trials/texas">Texas</a>, a total of 3699 sites across the world have been running tests for this drug.

Q: What aims is this research endeavor intending to achieve?

The primary purpose of this medical trial, which will last around 12 months, is to identify the maximum tolerated dosage and recommended phase 2 dose of peposertib (M3814) when taken with hypofractionated radiation and avelumab. Secondary objectives include monitoring for adverse events as outlined by CTCAE v5.0, determining progression-free survival through Kaplan-Meier estimates, and assessing pharmacokinetics of avelumab using enzyme-linked immunosorbent assay (ELISA).

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 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

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

Computed Tomography

2017

Completed Phase 2

~2720

Hypofractionated Radiation Therapy

2016

Completed Phase 2

~130

Biospecimen Collection

2004

Completed Phase 2

~1700

Peposertib

2021

Completed Phase 1

~20

Avelumab

2018

Completed Phase 2

~2450

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,666 Previous Clinical Trials

40,925,904 Total Patients Enrolled

Kristen R SpencerPrincipal InvestigatorLaura and Isaac Perlmutter Cancer Center at NYU

1 Previous Clinical Trials

105 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many locations can potential participants access this research project?

"This medical research is actively enrolling from 4 distinct trial sites. Besides Richmond, New Brunswick and Chicago, there are other locations that can be found with ease. To reduce the amount of travelling required, it might be beneficial to pick a nearby clinic if you decide to join this clinical trial."

Answered by AI

Is there still an opportunity for participants to join this clinical trial?

"Affirmative, the information on clinicaltrials.gov attests that this medical trial is presently recruiting participants. It was published to the site on December 23rd 2019 and has been modified as recently as October 15th 2022; 39 individuals are required from four locations."

Answered by AI

Is this a pioneering clinical trial?

"As of now, 115 active clinical trials on Peposertib are occurring across 1024 cities and 52 nations. The inaugural trial for the drug commenced in 2014 with EMD Serono Research & Development Institute as its sponsor; 204 patients participated in this Phase 2 study which was concluded successfully. In the years since then, 130 studies have been completed."

Answered by AI

How many participants are included in this medical experiment?

"This trial necessitates 39 qualified individuals to join the research. Participants can be sourced from different medical facilities, with two primary locations being Virginia Commonwealth University/Massey Cancer Center in Richmond and Rutgers Cancer Institute of New jersey in New Brunswick."

Answered by AI

Has there been any previous research into the efficacy of Peposertib?

"Currently, there are 115 medical studies focused on Peposertib; 10 of these active trials are at the Phase 3 stage. Though most locations for these experiments lie in Houston, Texas, a total of 3699 sites across the world have been running tests for this drug."

Answered by AI

What aims is this research endeavor intending to achieve?

"The primary purpose of this medical trial, which will last around 12 months, is to identify the maximum tolerated dosage and recommended phase 2 dose of peposertib (M3814) when taken with hypofractionated radiation and avelumab. Secondary objectives include monitoring for adverse events as outlined by CTCAE v5.0, determining progression-free survival through Kaplan-Meier estimates, and assessing pharmacokinetics of avelumab using enzyme-linked immunosorbent assay (ELISA)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2020. "Testing the Combination of New Anti-cancer Drug Peposertib With Avelumab and Radiation Therapy for Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04068194.

All > Intrahepatic Cholangiocarcinoma > Bile Duct Cancer