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Monoclonal Antibodies

Cohort I Arm A (sotorasib, panitumumab) for Cancer

Phase 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

Human immunodeficiency virus (HIV)-infected patients no effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial

Patient must have completed full treatment cycle 21 days prior to EAY191-E5 registration/randomization if they have received prior chemotherapy, biological cancer therapy, radiation therapy or an investigational agent/device. Patients must have recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or better from any adverse events due to prior cancer therapy (with the exception of alopecia)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial is testing a new treatment called AMG 510 (sotorasib) with or without panitumumab for patients with advanced solid tumors that have a specific genetic mutation (KR

Who is the study for?

This trial is for adults with advanced solid tumors that have spread and contain a specific mutation (KRAS G12C). Participants must have tried at least one standard treatment without success, be able to undergo a biopsy, and have good enough health to perform daily activities. They should not have any gastrointestinal issues that could affect medication absorption.Check my eligibility

What is being tested?

The study is testing the effectiveness of AMG 510 (sotorasib) alone or combined with panitumumab in treating KRAS G12C mutant solid tumors. Sotorasib aims to stop cancer cells from multiplying by blocking an abnormal protein, while panitumumab targets cancer cell growth.See study design

What are the potential side effects?

Possible side effects include reactions related to the immune system's response to these drugs, skin problems due to panitumumab, liver issues from sotorasib, as well as general symptoms like tiredness and digestive discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am HIV positive, on effective treatment, and my viral load has been undetectable for 6 months.

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I finished my last cancer treatment 21 days ago and have mostly recovered from side effects.

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I have not been treated with KRAS G12C and EGFR inhibitors together.

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I can swallow pills and don't have major stomach issues affecting medication absorption.

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I am enrolled in EAY191 and assigned to ComboMATCH for an actionable mutation.

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My cancer has worsened after receiving standard treatment for its advanced stage.

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I do not have severe nerve pain or damage.

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My cancer is advanced or has spread, and it has worsened after treatment.

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I am 18 years old or older.

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My cancer has a KRAS G12C mutation.

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My cancer is confirmed to be advanced or has spread to other parts.

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I do not have colorectal or non-small cell lung cancer.

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I have never been treated with a KRAS G12C inhibitor.

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My cancer progressed after treatment with a KRAS G12C inhibitor.

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I can take care of myself but might not be able to do heavy physical work.

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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 never had non-infectious lung inflammation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Best objective response (Cohort II)

Overall response rate (ORR) (Cohort II)

Progression-free survival (PFS) (Cohort I)

Secondary outcome measures

Disease control rates (Cohort I)

ORR (Cohort I)

OS (Cohort II)

+2 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Cohort II (sotorasib, panitumumab)Experimental Treatment6 Interventions

Patients receive combination therapy as in Arm A.

Group II: Cohort I Arm A (sotorasib, panitumumab)Experimental Treatment6 Interventions

Patients receive sotorasib PO QD on days 1-28 and panitumumab IV on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples, biopsy, and CT or MRI on study.

Group III: Cohort I Arm B (sotorasib)Active Control5 Interventions

Patients receive sotorasib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross-over to cohort II. Patients also undergo collection of blood samples, biopsy, and CT or MRI on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Biospecimen Collection

2004

Completed Phase 2

~1700

Biopsy

2014

Completed Phase 4

~1090

Sotorasib

2021

Completed Phase 1

~370

Panitumumab

2020

Completed Phase 3

~7130

Computed Tomography

2017

Completed Phase 2

~2720

0 / 17Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,672 Previous Clinical Trials

40,926,336 Total Patients Enrolled

Kristen R SpencerPrincipal InvestigatorECOG-ACRIN Cancer Research Group

1 Previous Clinical Trials

101 Total Patients Enrolled

Frequently Asked Questions

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

Are there any ongoing efforts to enroll participants in this research study?

"Information from clinicaltrials.gov verifies that this current trial is actively seeking candidates. Initially shared on 10/14/2024, the most recent revision was made on 2/2/2024."

Answered by AI

What is the current number of individuals being admitted into this research investigation?

"Indeed, the details on clinicaltrials.gov affirm that this medical investigation is actively seeking suitable participants. This trial was initially shared on October 14th, 2024, and subsequently revised on February 2nd of the same year. The research aims to recruit a total of 105 patients across eleven designated sites."

Answered by AI

What are the principal goals that this medical study aims to achieve?

"This study aims to assess the Best objective response (Cohort II) from enrollment to documented disease progression or mortality for all causes within a 3-year period. Secondary endpoints involve evaluating Overall survival (OS) (Cohort I), Disease control rates (Cohort I), and PFS (Cohort II). OS distributions by treatment will be estimated with confidence intervals at 6 and 12 months, while the OS hazard ratio will be assessed using a Cox proportional hazards model. Additionally, disease control rates in each arm will undergo comparison through Fisher's exact test, along with computation of exact 90% confidence intervals. Lastly"

Answered by AI

Has the combination of sotorasib and panitumumab in Cohort I Arm A been granted approval by the FDA?

"Based on our assessment at Power, the safety rating for Cohort I Arm A (sotorasib, panitumumab) is a 2. This evaluation is influenced by it being a Phase 2 trial where some data supports safety but efficacy remains unconfirmed."

Answered by AI

Are there a multitude of medical facilities in Canada participating in this study?

"At present, this research endeavor is operational at 11 distinct locations. Noteworthy sites include Chelsea, Brighton, and Ann Arbor among others. Opting for the site closest to you upon enrollment could help mitigate travel requirements."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Testing the Use of AMG 510 (Sotorasib) and Panitumumab as a Targeted Treatment for KRAS G12C Mutant Solid Tumor Cancers (A ComboMATCH Treatment Trial)

2024. "Testing the Use of AMG 510 (Sotorasib) and Panitumumab as a Targeted Treatment for KRAS G12C Mutant Solid Tumor Cancers (A ComboMATCH Treatment Trial)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05638295.