Trial record 1 of 2 for:
EAY191-E5
Testing the Use of AMG 510 (Sotorasib) and Panitumumab as a Targeted Treatment for KRAS G12C Mutant Solid Tumor Cancers (A ComboMATCH Treatment Trial)
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| ClinicalTrials.gov Identifier: NCT05638295 |
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Recruitment Status :
Recruiting
First Posted : December 6, 2022
Last Update Posted : May 20, 2024
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Sponsor:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
National Cancer Institute (NCI)
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Advanced Malignant Solid Neoplasm Metastatic Malignant Solid Neoplasm | Procedure: Biopsy Procedure: Biospecimen Collection Procedure: Computed Tomography Procedure: Magnetic Resonance Imaging Biological: Panitumumab Drug: Sotorasib | Phase 2 |
Show detailed description
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 105 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized Phase II Study of AMG 510 (Sotorasib) With or Without Panitumumab in Advanced Solid Tumors: A ComboMATCH Treatment Trial |
| Estimated Study Start Date : | October 14, 2024 |
| Estimated Primary Completion Date : | December 31, 2025 |
| Estimated Study Completion Date : | December 31, 2025 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
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Experimental: Cohort I Arm A (sotorasib, panitumumab)
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.
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Procedure: Biopsy
Undergo tumor biopsy
Other Names:
Procedure: Biospecimen Collection Undergo collection of blood
Other Names:
Procedure: Computed Tomography Undergo CT scan
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Procedure: Magnetic Resonance Imaging Undergo MRI
Other Names:
Biological: Panitumumab Given IV
Other Names:
Drug: Sotorasib Given PO
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Active Comparator: Cohort I Arm B (sotorasib)
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.
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Procedure: Biopsy
Undergo tumor biopsy
Other Names:
Procedure: Biospecimen Collection Undergo collection of blood
Other Names:
Procedure: Computed Tomography Undergo CT scan
Other Names:
Procedure: Magnetic Resonance Imaging Undergo MRI
Other Names:
Drug: Sotorasib Given PO
Other Names:
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Experimental: Cohort II (sotorasib, panitumumab)
Patients receive combination therapy as in Arm A.
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Procedure: Biopsy
Undergo tumor biopsy
Other Names:
Procedure: Biospecimen Collection Undergo collection of blood
Other Names:
Procedure: Computed Tomography Undergo CT scan
Other Names:
Procedure: Magnetic Resonance Imaging Undergo MRI
Other Names:
Biological: Panitumumab Given IV
Other Names:
Drug: Sotorasib Given PO
Other Names:
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Primary Outcome Measures :
- Progression-free survival (PFS) (Cohort I) [ Time Frame: From registration to documented disease progression or death from any cause, assessed up to 3 years ]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.
- Best objective response (Cohort II) [ Time Frame: From the start of the treatment until disease progression/recurrence, assessed up to 3 years ]Will be evaluated using the criteria defined by Response Evaluation Criteria in Solid Tumors (RECIST]) version 1.1 for patients with solid tumors.
- Overall response rate (ORR) (Cohort II) [ Time Frame: From the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 3 years ]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.
Secondary Outcome Measures :
- Overall survival (OS) (Cohort I) [ Time Frame: Up to 3 years ]OS distributions by treatment will be estimated and 90% confidence intervals on estimated rates at 6 and 12 months will be reported. The OS hazard ratio will be estimated using Cox proportional hazards model and a 90% confidence interval reported.
- ORR (Cohort I) [ Time Frame: Up to 3 years ]Will be compared using Fisher's exact test and exact 90% confidence intervals for the rates in each arm will be computed.
- Disease control rates (Cohort I) [ Time Frame: From the start of the treatment until the criteria for progression are met, assessed up to 3 years ]Will be compared using Fisher's exact test and exact 90% confidence intervals for the rates in each arm will be computed.
- PFS (Cohort II) [ Time Frame: At 6 and 12 months, assessed up to 3 years ]Will be estimated and 90% confidence intervals on estimated rates will be reported.
- OS (Cohort II) [ Time Frame: At 6 and 12 months, assessed up to 3 years ]Will be estimated and 90% confidence intervals on estimated rates will be reported.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patient must have enrolled onto EAY191 and must have been given a treatment assignment to ComboMATCH to EAY191-E5 based on the presence of an actionable mutation as defined in EAY191
- Patient must be enrolled on the ComboMATCH Registration Protocol (EAY191) at the time of registration/randomization to the EAY191-E5 study
- Patient must be >= 18 years of age
- Patient must have a KRAS G12C alteration as determined by the ComboMATCH screening assessment
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Patient must have disease that can be safely biopsied and agree to a pre-treatment biopsy or have tissue available from within 12 months prior to the date of registration on the ComboMATCH Registration Trial (EAY191-E5)
- NOTE: The current actionable marker of interest (aMOI)/actionable alteration list for this treatment trial can be found on the Cancer Trials Support Unit (CTSU) website: www.ctsu.org (final URL pending)
- NOTE: Novel/Dynamic aMOI can be submitted for review per the process described in the ComboMATCH registration protocol
- Patient must have cytologically/histologically confirmed advanced/metastatic solid tumor
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Patient must have progressed on at least one line of standard of care therapy in the advanced/metastatic setting
- NOTE: Patients who have progressed on a prior human epidermal growth factor receptor (EGFR) inhibitor will meet this criterion
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2 (or Karnofsky performance status >= 60%)
- Patient must have at least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) documented by imaging obtained within 28 days prior to registration/randomization
- Patient must not have any serious active infection within 4 weeks prior to EAY191-E5 registration/randomization (e.g., requiring hospitalization and/or intravenous [IV] antibiotics) or currently receiving oral or IV antibiotics for the treatment of infection. Patients receiving prophylactic antibiotics are eligible
- Patient must have the ability to retain oral medication and not have any clinically significant gastrointestinal abnormalities that might alter absorption
- Patient must not have any history of or current evidence of non-infectious interstitial lung disease (ILD)/pneumonitis
- Patient must not have a history of allergic reactions attributed to either of the study agents or to agents of similar chemical or biologic composition
- 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)
- Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to registration/randomization to rule out pregnancy. A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
- Patient must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study and for at least 6 months after the last dose of protocol treatment. Patients must not breastfeed while receiving protocol treatment and for one week (7 days) after the last dose of AMG 510 (sotorasib) and 2 months after the last dose of panitumumab
- Patients must not have neuropathy ≥ grade 2 within 14 days prior to registration/randomization
- Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression
- Human immunodeficiency virus (HIV)-infected patients no effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
- Patients with known history or current symptoms of cardiac history, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trail, patients should be class 2B or better
- Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (obtained ≤ 28 days prior to protocol registration/randomization)
- Aspartate aminotransferase (AST) (serum (glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase ([SGPT]) < 3 x institutional upper limit of normal (obtained ≤ 28 days prior to protocol registration/randomization)
- Creatinine =< 1.5 x institutional ULN OR creatinine clearance > 50 mL/min/1.73 m^2 for patients with creatinine levels > 1.5 mg/dL as per Cockcroft-Gault (obtained ≤ 28 days prior to protocol registration/randomization)
- COHORT I: Patient must not have colorectal cancer or non-small cell lung cancer
- COHORT I: Patient must not have been previously treated with a KRAS G12C inhibitor
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COHORT II: Patient must have progressed after treatment at the recommended phase II dose (RP2D) of any KRAS G12C inhibitor
- NOTE: Patients on cohort 1 who experience progression on Regimen 2 (AMG 510 [sotorasib] alone) may be eligible to enroll on cohort 2 and receive combination treatment with panitumumab and AMG 510 (sotorasib). Patients must meet performance status requirements and laboratory values as above and must be begin treatment within 7 days of enrollment. Migration to cohort 2 must take place within 6 months of progression, with no intervening anti-cancer therapy given.
- NOTE: Cohort migration following disease progression is dependent on a slot being available. MATCHBox makes the new treatment assignment following initiation of a step 2 registration for this treatment trial
- COHORT II: Patient must not have been previously treated with a KRAS G12C inhibitor in combination with an EGFR inhibitor
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05638295
Locations
Show 72 study locations
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Kristen R Spencer | ECOG-ACRIN Cancer Research Group |
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT05638295 |
| Other Study ID Numbers: |
NCI-2022-09876 NCI-2022-09876 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) EAY191-E5 ( Other Identifier: ECOG-ACRIN Cancer Research Group ) EAY191-E5 ( Other Identifier: CTEP ) U10CA180820 ( U.S. NIH Grant/Contract ) |
| First Posted: | December 6, 2022 Key Record Dates |
| Last Update Posted: | May 20, 2024 |
| Last Verified: | April 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page. |
| URL: | https://grants.nih.gov/policy/sharing.htm |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
Additional relevant MeSH terms:
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Neoplasms Antineoplastic Agents, Immunological Panitumumab Sotorasib Antibodies Immunoglobulins |
Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |