RecruitingPhase 3

Zanzalintinib Alone or in Combination With Pembrolizumab and Berahyaluronidase Alfa in Participants With Colorectal Cancer With Molecular Residual Disease

Randomized Phase 3 Study of Zanzalintinib ± Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) Versus Placebo in Participants With Colorectal Cancer With Stage II/III Molecular Residual Disease Following Definitive Therapy

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests zanzalintinib alone or with pembrolizumab and berahyaluronidase alfa against a placebo (a treatment with no active drug). It is for people with treated stage II or III colon or rectal cancer who have cancer DNA in their blood but no cancer seen on scans.

The primary objective of this study is to evaluate the effectiveness of zanzalintinib + Pembrolizumab (+) berahyaluronidase alfa and zanzalintinib alone compared with placebo.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have stage II or III adenocarcinoma of the colon or rectum, a cancer that starts in gland cells, confirmed by a tissue test.
  • Have tumor test results showing MSS, MSI-low, or pMMR. These results describe how well cancer cells repair DNA.
  • Have finished the main treatment for colon or rectal cancer.
  • Have cancer DNA found in the blood by the Natera Signatera test.
  • Have no cancer seen on chest, belly, and pelvis scans using CT, or chest CT with belly and pelvis MRI.

Who can't join

  • Have had an organ transplant or a stem cell transplant from another person.
  • Have another cancer that is growing or has needed active treatment in the past 2 years.
  • Have had immune checkpoint inhibitors (drugs that help the immune system fight cancer) or VEGFR inhibitors (drugs that block signals for blood vessel growth).
  • Have had colon or rectal cancer that needed cancer drugs working throughout the body before the main treatment.
  • Have received cancer drugs working throughout the body, including study drugs, or radiation after finishing the main treatment.
  • Have received a live, weakened vaccine within 30 days before being assigned to a study group, or receive one during treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Key Inclusion Criteria: * Histologically confirmed diagnosis of Stage II or III adenocarcinoma of colon or rectum. * Documented local MSI and/or mismatch repair (MMR) test result demonstrating MSS, MSI-low, or pMMR status. * Colon or rectal cancer with completed definitive therapy. * ctDNA-positive based on local testing using the Natera Signatera tissue-informed molecular residual disease (MRD) assay. * No radiographic evidence of disease, as confirmed by a negative baseline computed tomography (CT) of the chest, abdomen, and pelvis (CAP), or CT of chest and magnetic resonance imaging (MRI) of abdomen/pelvis. Key Exclusion Criteria: * History of solid organ or allogeneic stem cell transplant. * Known additional malignancy that is progressing or has required active treatment within the past 2 years. * Prior treatment with immune checkpoint inhibitors (ICIs) or Vascular endothelial growth factor receptor (VEGFR) inhibitors. * History of CRC requiring systemic anticancer therapy prior to the definitive therapy. * Use of systemic anticancer therapy (including investigational therapy) or radiation therapy after the completion of definitive therapy. * Administration of a live, attenuated vaccine within 30 days of randomization and during treatment. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study sites (13)

IA

NE

  • Oncology Hematology West, PC dba Nebraska Cancer Specialists - Grand Island · Grand Island, NE 68803More trials in Grand Island
  • Oncology Hematology West, PC dba Nebraska Cancer Specialists - Regional · Grand Island, NE 68803More trials in Grand Island
  • Oncology Hematology West, PC dba Nebraska Cancer Specialists - Methodist · Omaha, NE 68114More trials in Omaha
  • Oncology Hematology West, PC dba Nebraska Cancer Specialists - Bergan · Omaha, NE 68124More trials in Omaha
  • Oncology Hematology West, PC dba Nebraska Cancer Specialists - Legacy · Omaha, NE 68130More trials in Omaha
  • Oncology Hematology West, PC dba Nebraska Cancer Specialists - Papillion · Papillion, NE 68046More trials in Papillion

NJ