A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012)

A vizsgálat adatai

Ki végzi

Merck Sharp & Dohme LLC

Azonosító

NCT06997497EU 2024-517232-22-00

A regiszteradat frissítve

2026. november 12.

Eredeti leírás

Researchers are looking for other ways to treat locally advanced or metastatic colorectal cancer (mCRC) that is unresectable and has a gene mutation called KRAS G12C.A teljes eredeti leírásKevesebb

A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084, Cetuximab, and mFOLFOX6 Versus mFOLFOX6 With or Without Bevacizumab as First-line Treatment of Participants With KRAS G12C-mutant, Locally Advanced Unresectable or Metastatic Colorectal Cancer (KANDLELIT-012)

Researchers are looking for other ways to treat locally advanced or metastatic colorectal cancer (mCRC) that is unresectable and has a gene mutation called KRAS G12C.

Standard (or usual) treatments for this type of colorectal cancer may include mFOLFOX6 with or without bevacizumab. Researchers want to learn if adding calderasib (the study medicine) and cetuximab to mFOLFOX6 can treat locally advanced or mCRC with the KRAS G12C mutation. Calderasib and cetuximab are targeted therapies.

The goals of this study are to learn:

* About the safety of calderasib with cetuximab and mFOLFOX6 and if people tolerate the treatments * If people who receive calderasib with cetuximab and mFOLFOX6 live longer without mCRC growing or spreading compared to people who receive mFOLFOX6 with or without bevacizumab.

Bevonási feltételek: The main inclusion criteria include but are not limited to the following:; Has a histologically confirmed diagnosis of locally advanced unresectable or metastatic (unresectable Stage III or Stage IV as defined by American Joint Committee on Cancer [AJCC] eighth edition) colorectal adenocarcinoma; Part 2 only: Has not received systemic anticancer therapy for locally advanced unresectable or metastatic colorectal cancer; an exception is permitted for 1-2 cycles of FOLFOX or 1 cycle of CAPOX as optional chemotherapy before or during the screening period; Demonstrates presence of a Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation; Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART); Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load; Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable.

Kizáró feltételek: Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, chronic diarrhea); Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization, with the exception of the optional chemotherapy; Has 1 or more conditions that, in the opinion of the investigator, make the participant ineligible for treatment with bevacizumab; Has not adequately recovered from major surgery or have ongoing surgical complications; Has uncontrolled, significant cardiovascular disease or cerebrovascular disease; HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease; Has known additional malignancy that is progressing or has required active treatment within the past 3 years; Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis or leptomeningeal disease; Has active infection requiring systemic therapy; Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease; The main exclusion criteria include but are not limited to the following:; Has known partial or complete dihydropyrimidine dehydrogenase (DPD) deficiency.

ClinicalTrials.gov NCT06997497 · EU CTIS 2024-517232-22-00