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A Study to Evaluate the Efficacy of VVD-133214 in Combination With Pembrolizumab Compared With Pembrolizumab Alone in Participants With Advanced Cancer of the Colon or Rectum

RecruitingPhase 2Ages 18 Years - anyAllVividion Therapeutics, Inc.
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In plain words

What the trial is, and whether it could suit you

Researchers are looking for a better way to treat people with advanced colorectal cancer. Colorectal cancer (cancer of the colon or rectum) is one of the most common cancers worldwide. Treatments include surgery, chemotherapy, radiotherapy, and immunotherapy; however, these treatments do not work for everyone, may cause serious adverse events or may stop working eventually. New treatments and treatment combinations are needed, especially for cancers that cannot be removed with surgery or that have spread to other parts of the body (called advanced or metastatic cancer). Cells normally repair themselves when mistakes happen as they divide. But in some people with cancer, the repair system does not work properly because of a problem called dMMR (deficient mismatch repair). As a result, mistakes build up in the cell's DNA, leading to a condition called MSI (microsatellite instability). Ov

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1 * Have a known microsatellite instability (MSI) and/or deficient mismatch repair (dMMR) tumor status confirmed per local standard of care (SoC), and have histologically or cytologically documented advanced (unresectable and/or metastatic) colorectal adenocarcinoma (CRC) * No prior systemic treatment for metastatic disease and not amenable to curative resection * Participants must have documented MSI and/or dMMR tumor status determined as part of the routine diagnostic workup in a certified laboratory * Availability of formaldehyde-fixed paraffin-embedded (FFPE) archival tumor tissue for submission to Sponsor/central laboratory for retrospective central testing including a copy of a redacted pathology report if available * Presence of measurable disease according to RECIST v1.1 * Adequate hematologic and end-organ function, defined using laboratory results obtained within 14 days prior to first dose of study treatment * Females of childbearing potential must have negative serum pregnancy test before starting study treatment Exclusion Criteria: * Prior systemic treatment for advanced CRC. Participants may have received prior adjuvant chemotherapy as long as disease progression occurred at least 12 months after the last dose of adjuvant treatment * Prior treatment with adjuvant immunotherapy (e.g., anti-PD-1, anti-PD-L1, anti-PD-L2 agent, or anti-CTLA-4 agent, or any other antibody or drug specifically targeting T cell co-stimulation or immune checkpoint pathways, including prior therapy with anti-tumor vaccines or other immuno-stimulatory antitumor agents, etc.) * Known active or uncontrolled central nervous system (CNS) or brain metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control) and/or carcinomatous meningitis * Patients with active or history of autoimmune disease or immune deficiency that has required treatment in past 2 years * History of malignancy other than CRC, within 5 years prior to screening. Participants with Lynch syndrome are not excluded. * Participants requiring treatment with systemic immunosuppressive medication (such as corticosteroids) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment * Participants with active hepatitis B, hepatitis C or HIV * Participants with known Werner Syndrome (WRN) * Prior treatment with any WRN helicase inhibitor
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What it tests

  • VVD-133214
  • Pembrolizumab
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Where

122 sites
University of Arizona Cancer Center - North Campus
Tucson, United States
University of Michigan Rogel Cancer Center
Ann Arbor, United States
Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - Detroit
Detroit, United States
Mary Babb Randolph Cancer Center
Morgantown, United States
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
Centro Medico Fleischer
Buenos Aires, Argentina
Instituto Alexander Fleming
Buenos Aires, Argentina
Investigaciones Oncológicas C Colón
Mar del Plata, Argentina

…and 114 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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