ACTIVE_NOT_RECRUITING

SX-682 and Nivolumab for the Treatment of RAS-Mutated, MSS Unresectable or Metastatic Colorectal Cancer, the STOPTRAFFIC-1 Trial

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase Ib/II trial studies the side effects and best dose of SX-682 that can be given alone and in combination with nivolumab in treating patients with RAS-Mutated, microsatellite stable (MSS) colorectal cancer that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). SX-682 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving SX-682 alone and together with nivolumab may kill more tumor cells.

Official Title

Phase Ib/II Trial of SX-682 in Combination With Nivolumab for Refractory RAS Mutated (RAS) Microsatellite Stable (MSS) Metastatic Colorectal Cancer (mCRC) (STOPTRAFFIC-1)

Quick Facts

Study Start:2020-10-14

Study Completion:2026-01-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04599140

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Written Informed Consent and HIPAA Authorization 1. Subjects must have the nature of the study explained to them. 2. Non-English speaking patients will be eligible for participation with involvement of the MD Anderson Language Assistance department in the informed consent process (per MD Anderson SOP 04_Informed Consent Process). 3. Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, pharmacokinetic collections, and other requirements of the study. 4. Subjects must provide a signed and dated IRB approved written informed consent form (ICF) in accordance with regulatory and institutional guidelines for both the study and exploratory biomarker analyses (e.g., CMS4 and others) on archival tissue. 5. Subjects must provide a signed and dated Health Insurance Portability and Accountability Act (HIPAA) authorization. 6. The ICF and HIPAA authorization must be obtained before conducting any procedures that do not form a part of the subject's normal care. 7. After signing the ICF and HIPAA Authorization, subjects will be evaluated for study eligibility during the Screening Period (no more than 28 days before study drug administration) according to the following further inclusion/	2. Target Population 1. Men and women, ages \> 18 years of age. Both men and women of all races and ethnic groups, regardless of preferred language, are eligible for this trial. 2. Histologically or cytologically confirmed adenocarcinoma of the colon or the rectum that is metastatic or unresectable. 3. Tumor is determined to be RAS-mutated (KRAS or NRAS) and microsatellite stable/proficient in mismatch repair, as assessed by IHC and/or PCR/NGS in a CLIA environment. 4. Received at least two prior regimens of therapy for unresectable or metastatic CRC including fluoropyrimidine-, oxaliplatin-, and irinotecan-based regimens. Patients who relapse within 6 months of adjuvant chemotherapy composed of oxaliplatin and a fluoropyrimidine will have their adjuvant therapy count as one prior regimen. 5. For the expansion cohort, pre-treatment primary tumor tissue (i.e., archived paraffin-embedded) or from an unresectable metastatic site must be available for biomarker analyses. Biopsy should be excisional or core needle. Fine needle aspirates or other cytology samples are insufficient. 6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 (Appendix 1). 7. Must have measurable disease with at least 1 unidimensional measurable lesion per RECIST v1.1 (see Appendix 2). 8. Prior radiotherapy must have been completed at least 2 weeks prior to study drug administration. 9. Screening laboratory values must meet the following criteria and should be obtained within 14 days prior to first dose: 10. Glomerular filtration rate (GFR) calculated by Cockcroft-Gault formula \>60 ml/min. 11. Life expectancy \> 12 weeks as judged by the treating physician. 12. Subject Re-enrollment: This study permits the re-enrollment of a subject that has discontinued the study as a pre-treatment failure (i.e., subject has not been treated with SX-682). If re-enrolled, the subject must be re-consented. 1. Target Disease Exceptions 2. Medical History and Concurrent Diseases

Inclusion Criteria

Exclusion Criteria

1. Written Informed Consent and HIPAA Authorization
1. Subjects must have the nature of the study explained to them.
2. Non-English speaking patients will be eligible for participation with involvement of the MD Anderson Language Assistance department in the informed consent process (per MD Anderson SOP 04_Informed Consent Process).
3. Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, pharmacokinetic collections, and other requirements of the study.
4. Subjects must provide a signed and dated IRB approved written informed consent form (ICF) in accordance with regulatory and institutional guidelines for both the study and exploratory biomarker analyses (e.g., CMS4 and others) on archival tissue.
5. Subjects must provide a signed and dated Health Insurance Portability and Accountability Act (HIPAA) authorization.
6. The ICF and HIPAA authorization must be obtained before conducting any procedures that do not form a part of the subject's normal care.
7. After signing the ICF and HIPAA Authorization, subjects will be evaluated for study eligibility during the Screening Period (no more than 28 days before study drug administration) according to the following further inclusion/

2. Target Population
1. Men and women, ages \> 18 years of age. Both men and women of all races and ethnic groups, regardless of preferred language, are eligible for this trial.
2. Histologically or cytologically confirmed adenocarcinoma of the colon or the rectum that is metastatic or unresectable.
3. Tumor is determined to be RAS-mutated (KRAS or NRAS) and microsatellite stable/proficient in mismatch repair, as assessed by IHC and/or PCR/NGS in a CLIA environment.
4. Received at least two prior regimens of therapy for unresectable or metastatic CRC including fluoropyrimidine-, oxaliplatin-, and irinotecan-based regimens. Patients who relapse within 6 months of adjuvant chemotherapy composed of oxaliplatin and a fluoropyrimidine will have their adjuvant therapy count as one prior regimen.
5. For the expansion cohort, pre-treatment primary tumor tissue (i.e., archived paraffin-embedded) or from an unresectable metastatic site must be available for biomarker analyses. Biopsy should be excisional or core needle. Fine needle aspirates or other cytology samples are insufficient.
6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 (Appendix 1).
7. Must have measurable disease with at least 1 unidimensional measurable lesion per RECIST v1.1 (see Appendix 2).
8. Prior radiotherapy must have been completed at least 2 weeks prior to study drug administration.
9. Screening laboratory values must meet the following criteria and should be obtained within 14 days prior to first dose:
10. Glomerular filtration rate (GFR) calculated by Cockcroft-Gault formula \>60 ml/min.
11. Life expectancy \> 12 weeks as judged by the treating physician.
12. Subject Re-enrollment: This study permits the re-enrollment of a subject that has discontinued the study as a pre-treatment failure (i.e., subject has not been treated with SX-682). If re-enrolled, the subject must be re-consented.
1. Target Disease Exceptions
2. Medical History and Concurrent Diseases

Contacts and Locations

Principal Investigator

Alisha Bent, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Alisha Bent, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-10-14

Study Completion Date2026-01-31

Study Record Updates