This study is currently recruiting participants.
Number
002060-C
Sponsoring Institute
National Cancer Institute (NCI)
Recruitment Detail
Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 18 Years Max Age: 120 Years
Referral Letter Required
No
Population Exclusion(s)
Children;Pregnant Women
Keywords
Targeted Therapy; Combination Therapy; Advanced Solid Tumors; Precision Oncology; KRAS G12C Inhibition
Recruitment Keyword(s)
None
Condition(s)
Neoplasms; Pancreatic Neoplasms
Investigational Drug(s)
Panitumumab Sotorasib
Investigational Device(s)
Intervention(s)
Drug: Panitumumab Drug: Sotorasib
Supporting Site
National Cancer Institute
Cancers that have certain gene mutations are among the most difficult to treat. Mutation in the KRAS gene in particular is a common cause of many pancreatic, lung, bowel, and other cancers. No effective treatments have yet been found for cancers with KRAS mutations.
Objective:
To test the drug AMG 510 (Sotorasib), with or without a second drug, panitumumab, in people who have cancers with KRAS mutations. AMG 510 has been approved to treat other cancers. Panitumumab is an investigational drug.
Eligibility:
People aged 18 years and older who are enrolled in the ComboMATCH protocol. They must have advanced solid tumors with a KRAS gene mutation.
Design:
Participants will be screened. They will have blood tests and a biopsy: A sample of tissue will be cut from their tumor. A recent biopsy sample may be used, if one is available.
AMG 510 is a pill taken by mouth. All participants will take these pills once a day during 28-day treatment cycles. They will keep a diary to record when they take each pill.
Panitumumab is administered through a tube attached to a needle inserted into a vein in the arm. Some participants will receive this drug on days 1 and 15 of each 28-day cycle.
All participants will have physical exams and blood tests every 2 weeks during treatment. They will have imaging scans once every 2 cycles.
Participants may remain in the study as long as the treatment is helping them.
Participants will have a follow-up visit 30 days after treatment ends. After that, they will have follow-up visits every 90 days for 3 years.
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INCLUSION CRITERIA: Eligibility Criteria: All Patients - 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. - 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). --NOTE: The current actionable marker of interest (aMOI)/ actionable alteration list for this treatment trial can be found on the CTSU website: www.ctsu.org. --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. - 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 EGFR inhibitor will meet this criterion. - Patient must have an ECOG Performance Status of <=2 (or Karnofsky Performance Status >= 60%). - Patient must have at least one measurable lesion as defined by 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 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 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 CNS-directed therapy shows no evidence of progression. - 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. - Patients must have adequate organ function as defined below (these labs must be obtained <= 28 days prior to protocol registration/randomization): --Total bilirubin <= 1.5 X institutional ULN --AST(SGOT)/ALT(SGPT) < 3 X institutional upper limit of normal; --Creatinine <=1.5 X institutional ULN OR --Creatinine clearance >50 mL/min/1.73 m2 for patients with creatinine levels >1.5 mg/dL as per Cockcroft-Gault Eligibility Criteria: Cohort 1 Only - Patient must not have colorectal cancer or non-small cell lung cancer. - Patient must not have been previously treated with a KRAS G12C inhibitor. Eligibility Criteria: Cohort 2 Only - Patient must have progressed after treatment at the 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. -Patient must not have been previously treated with a KRAS G12C inhibitor in combination with an EGFR inhibitor.
Eligibility Criteria: All Patients
- 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.
- 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).
--NOTE: The current actionable marker of interest (aMOI)/ actionable alteration list for this treatment trial can be found on the CTSU website: www.ctsu.org.
--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.
- 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 EGFR inhibitor will meet this criterion.
- Patient must have an ECOG Performance Status of <=2 (or Karnofsky Performance Status >= 60%).
- Patient must have at least one measurable lesion as defined by 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 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 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 CNS-directed therapy shows no evidence of progression.
- 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.
- Patients must have adequate organ function as defined below (these labs must be obtained <= 28 days prior to protocol registration/randomization):
--Total bilirubin <= 1.5 X institutional ULN
--AST(SGOT)/ALT(SGPT) < 3 X institutional upper limit of normal;
--Creatinine <=1.5 X institutional ULN
OR
--Creatinine clearance >50 mL/min/1.73 m2 for patients with creatinine levels >1.5 mg/dL as per Cockcroft-Gault
Eligibility Criteria: Cohort 1 Only
- Patient must not have colorectal cancer or non-small cell lung cancer.
- Patient must not have been previously treated with a KRAS G12C inhibitor.
Eligibility Criteria: Cohort 2 Only
- Patient must have progressed after treatment at the 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.
-Patient must not have been previously treated with a KRAS G12C inhibitor in combination with an EGFR inhibitor.
Principal Investigator
Referral Contact
For more information: