Phase II Study Comparing RO7198457 Treatment to Watchful Waiting in Patients with ctDNA-positive, Resected Stage II/III Colorectal Cancer

Sponsor: BioNTech SE

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04486378

Provider View

This clinical trial is comparing the effectiveness of a new treatment, RO7198457, against the standard approach of watchful waiting in patients with specific types of colorectal cancer that have been surgically removed but still show signs of cancer through ctDNA testing.

Patient Parameters

Program Overview

This study is being conducted at multiple sites and involves patients with Stage II or III colorectal cancer that has been surgically removed. The trial aims to compare the effects of the drug RO7198457 with the current practice of watchful waiting in patients who test positive for circulating tumor DNA (ctDNA), which indicates the presence of cancer cells in the blood.

Description

Participants in this trial will receive up to 15 doses of the investigational drug RO7198457 during the treatment period. The study is designed to evaluate whether this drug can help prevent cancer recurrence in patients who have undergone surgery for Stage II or III colorectal cancer and have detectable ctDNA, suggesting that cancer cells may still be present.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have Stage II or III rectal cancer, or Stage II (high risk) or III colon cancer that has been completely removed by surgery.
  • Must have detectable ctDNA before starting additional chemotherapy.
  • Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Must have adequate blood, bone marrow, and organ function.
  • Must provide a tumor sample for analysis.
  • Must have started standard chemotherapy within 8 to 10 weeks after surgery and completed at least 3 months of treatment.

Exclusion Criteria

  • Have uncontrolled illnesses as defined by the study.
  • Have tumors with high microsatellite instability.
  • Have received certain treatments before surgery or are on immunosuppressive medication.
  • Have unresolved side effects from previous cancer treatments.
  • Have developed metastatic disease during screening or standard treatment.
  • Have other cancers, except for certain non-invasive or curable types.
  • Have allergies or intolerance to the study drug.
  • Have had major surgery recently or plan to have surgery during the trial.
  • Have active hepatitis B or C infections, unless treated and resolved.
  • Have a history of HIV or test positive for HIV.
  • Have had a splenectomy.

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