NCT05638295|Active Not RecruitingPhase 2FDA Drug

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

A Randomized Phase II Study of AMG 510 (Sotorasib) With or Without Panitumumab in Advanced Solid Tumors: A ComboMATCH Treatment Trial

National Cancer Institute (NCI)ClinicalTrials.gov

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3 other identifiers

NCI-2022-09876EAY191-E5U10CA180820

Study Type

interventional

Target

105

Locations

1 country

Sites

180

Timeline

RegisteredDec 2022

StartedAug 2024

CompletionDec 2028

Brief Summary

This phase II ComboMATCH treatment trial tests how well AMG 510 (sotorasib) with or without panitumumab works in treating patients with KRAS G12C mutant solid tumors that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Sotorasib is in a class of medications called KRAS inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop or slow the spread of cancer cells. Panitumumab is in a class of medications called monoclonal antibodies. It works by slowing or stopping the growth of cancer cells. Giving combination panitumumab and sotorasib may kill more tumor cells in patients with advanced solid tumors with KRAS G12C mutation.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

105

participants targeted

Target at P50-P75 for phase_2

Timeline

32mo left

Started Aug 2024

Typical duration for phase_2

Geographic Reach

1 country

180 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.4 years study duration

Study Progress40%

Aug 2024Dec 2028

First Submitted

Initial submission to the registry

December 2, 2022

Completed

4 days until next milestone

First Posted

Study publicly available on registry

December 6, 2022

Completed

1.7 years until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed

4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

4.4 years

First QC Date

December 2, 2022

Last Update Submit

May 1, 2026

Conditions

Advanced Malignant Solid Neoplasm Metastatic Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (3)

Progression-free survival (PFS) (Cohort I)
PFS will be compared between the arms using a one-sided log rank test with 10% type I error. Cox's proportional hazards model will be used to estimate the PFS hazard ratio between the treatment arms and a two-sided 80% confidence interval will be reported (to correspond to the one-sided 10% type I error). Confidence intervals on most other quantities will use the two-sided 90% level.
From registration to documented disease progression or death from any cause, assessed up to 3 years
Best objective response (Cohort II)
Will be evaluated using the criteria defined by Response Evaluation Criteria in Solid Tumors) version 1.1 for patients with solid tumors.
From the start of the treatment until disease progression/recurrence, assessed up to 3 years
Overall response rate (ORR) (Cohort II)
The exact 90% confidence interval on the ORR (determined using the method of Atkinson and Brown) will be reported. If the number of analyzable cases is less than 35, a 5% one-sided test will still be used.
From the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 3 years

Secondary Outcomes (5)

Overall survival (OS) (Cohort I)
Up to 3 years
ORR (Cohort I)
Up to 3 years
Disease control rates (Cohort I)
From the start of the treatment until the criteria for progression are met, assessed up to 3 years
PFS (Cohort II)
At 6 and 12 months, assessed up to 3 years
OS (Cohort II)
At 6 and 12 months, assessed up to 3 years

Study Arms (3)

Cohort I Arm A (sotorasib, panitumumab)

EXPERIMENTAL

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.

Procedure: Biopsy ProcedureProcedure: Biospecimen CollectionProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingBiological: PanitumumabDrug: Sotorasib

Cohort I Arm B (sotorasib)

ACTIVE COMPARATOR

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.

Procedure: Biopsy ProcedureProcedure: Biospecimen CollectionProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingDrug: Sotorasib

Cohort II (sotorasib, panitumumab)

EXPERIMENTAL

Patients receive combination therapy as in Arm A.

Procedure: Biopsy ProcedureProcedure: Biospecimen CollectionProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingBiological: PanitumumabDrug: Sotorasib

Interventions

PanitumumabBIOLOGICAL

Given IV

Also known as: ABX-EGF, ABX-EGF Monoclonal Antibody, ABX-EGF, Clone E7.6.3, E7.6.3, Human IgG2K Monoclonal Antibody, MoAb ABX-EGF, MoAb E7.6.3, Monoclonal Antibody ABX-EGF, Monoclonal Antibody E7.6.3, Vectibix

Cohort I Arm A (sotorasib, panitumumab)Cohort II (sotorasib, panitumumab)

SotorasibDRUG

Given PO

Also known as: AMG 510, AMG-510, AMG510, Lumakras, Lumykras