Condition

Untreated, Unresectable, or Metastatic Colorectal Cancer

Purpose of the study

To evaluate the objective response of pumitamig in combination with FOLFOX/FOLFIRI vs bevacizumab + FOLFOX/FOLFIRI in participants with 1L metastatic colorectal cancer

Official Title

A Blinded, Randomized Phase 3 Study of Pumitamig in Combination with Chemotherapy Versus Bevacizumab in Combination with Chemotherapy in Participants with Previously Untreated, Unresectable, or Metastatic Colorectal Cancer NCT07221357

Who is eligible to participate?

Inclusion Criteria

• Previously untreated, histologically confirmed recurrent or metastatic colorectal adenocarcinoma, not amenable to curative surgery. Note: If participant has received adjuvant or neoadjuvant chemotherapy, there must be more than a 6-month gap (> 6 months) between the completion of that therapy and diagnosis of recurrent or metastatic disease.
• No known presence of dMMR or MSI-H CRC per historical results (a validated test should be used).
• No known presence of BRAF V600E mutation. · Measurable disease as defined by RECIST v1.1.
  ECOG Performance Status of 0 – 1. See APPENDIX 5 for ECOG Performance Status scale.

Exclusion Criteria

• Untreated known CNS metastases including brain, leptomeningeal and/or spinal cord compression. Note: Participants are eligible if CNS metastases are adequately treated, and participants are neurologically returned to baseline.
• Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
• Prior malignancy active within the previous 2 years, except for locally curable cancers (ie, basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast) and considered to be of low risk of recurrence.
• Significant cardiovascular disease such as myocardial infarction, unstable angina, arterial thrombosis or cerebrovascular accident within 6 months prior to randomization, or uncontrolled hypertension (≥ 160 systolic, ≥ 100 diastolic mmHg).
• Major surgery, open biopsy, or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of study intervention.
• Evidence of major coagulation disorders (eg, hemophilia).
  Known UGTIAI deficiency, if participant is planned to receive FOLFIRI.
• Any other serious or uncontrolled medical disorder as determined by the investigator.
  Participant is an individual of childbearing potential who is pregnant or breastfeeding, or who intends to become pregnant during participation in the study.
• Any contraindications or allergies to any of the study drugs of the chemotherapy regimen.

Register your interest

To register your interest or find out more information about this clinical trial, please email: enquiries@gallipoliresearch.org.au. 

Study location

Gallipoli Medical Research, Greenslopes Private Hospital, Brisbane