RightFit
RecruitingPhase 2

A Study of Novel Study Interventions and Combinations in Participants With Colorectal Cancer

A Phase II, Open-label, Multicenter, Master Protocol to Evaluate the Safety and Efficacy of Novel Study Interventions and Combinations in Participants With Colorectal Cancer (CANTOR)

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 to 130 Years
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 new treatments and treatment combinations for colorectal cancer, which starts in the colon or rectum. It looks at how safe they are and how well they work. A smaller study within it has added rules for people whose cancer has spread.

The main purpose of this study is to evaluate the safety and efficacy of novel study interventions and combinations in participants with Colorectal Cancer (CRC).

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

Eligibility

Who can join

  • Have colorectal adenocarcinoma, a gland-forming cancer, confirmed by a tissue test.
  • Provide a preserved tumor sample collected during regular care, and have cancer that can be measured on scans.
  • Be fully active or able to do light work, and be expected to live at least 12 weeks.
  • For the smaller study: scans must show no cancer spread to the liver.
  • For the smaller study: have cancer that has spread and has pMMR/MSS test results, meaning certain cell repair systems still work.
  • For the smaller study: no past whole-body treatment for cancer that has spread. Chemotherapy before or after surgery is allowed if it ended more than 6 months before cancer returned or spread.
  • For the smaller study: organs and bone marrow must work well enough. Weigh more than 35 kg (about 77 pounds) at screening and when assigned to a study group.
  • For the smaller study: birth control use must follow local rules for clinical studies.

Who can't join

  • Cancer has spread to the brain or spinal cord, or is pressing on the spinal cord.
  • A past severe allergy to any monoclonal antibody medicine or study treatment, or ongoing moderate or worse side effects from past cancer treatment.
  • A history of another separate cancer.
  • For the smaller study: cancer may be removable, and the care team plans surgery to remove it completely.
  • For the smaller study: current or past immune system diseases that attack the body, inflammatory diseases, or heart conditions.
  • For the smaller study: a past dangerous blood pressure crisis, brain problems from high blood pressure, or bleeding risks.
  • For the smaller study: blood clots in deep veins, lungs, or arteries; a mini-stroke; or a stroke.
  • For the smaller study: certain abnormal openings involving the belly, gut, windpipe, or food pipe, a hole in the gut, or a pocket of infection in the belly within 6 months before group assignment; or past treatment that works through the immune system.

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

Official eligibility criteria

Overall Inclusion Criteria: * Histopathologically confirmed colorectal adenocarcinoma. * Provision of FFPE tumor sample collected as per SoC. * Presence of measurable disease by RECIST 1.1 criteria. * ECOG performance status of 0 or 1. * Life expectancy ≥ 12 weeks at the time of screening. Substudy Inclusion Criteria: * No radiological evidence of liver metastasis. * No prior systemic therapy for mCRC, except for neoadjuvant/adjuvant chemotherapy where, \> 6 months have elapsed between completion of therapy and documented date of diagnosis of recurrent or metastatic disease. * Known pMMR/MSS status (only pMMR/MSS mCRC allowed). * Adequate organ and bone marrow function * Body weight \> 35 kg at screening and at randomization. * Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Overall Exclusion Criteria: * Central nervous system metastases or spinal cord compression * Known history of severe allergy to any monoclonal antibody or study intervention. * Any unresolved toxicity CTCAE Grade ≥ 2 from a previous anticancer therapy. * History of another primary malignancy. Substudy Exclusion Criteria: * Potentially resectable disease with multidisciplinary plan for radical surgery. * Active or prior documented autoimmune or inflammatory disorders or cardiac conditions. * Participants with a prior history of hypertensive crisis or hypertensive encephalopathy or bleeding risks. * Deep venous thrombosis, pulmonary embolism, arterial thrombosis, transient ischemic attack or cerebrovascular accident. * History of abdominal or tracheoesophageal fistula, GI perforation and/or fistulae, or intraabdominal abscess within 6 months prior to randomization. * Prior exposure to immune mediated therapy.

Study sites (14)

AZ

CA

DC

IL

MA

MD

MN

NJ

NY

OH

OR

PA

TN

TX