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New treatment option for Metastatic Colorectal Cancer
Official title A Study of Novel Study Interventions and Combinations in Participants With Colorectal Cancer
ClinicalTrials.gov ID: NCT06792695
What this study is testing
What is Volrustomig?
Volrustomig is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic colorectal cancer.
Also referred to as MEDI5752.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 130
You may be able to join if
- Overall
- 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.
You likely can't join if
- 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.
See the full eligibility criteria
- Overall
- 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
- 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Los Angeles, California, United States
- Washington D.C., District of Columbia, United States
- Chicago, Illinois, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Rochester, Minnesota, United States
- Trenton, New Jersey, United States
- Rochester, New York, United States
- Cleveland, Ohio, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- East Melbourne, Australia
- Wollongong, Australia
- Woodville South, Australia
- Victoria, British Columbia, Canada
- Barrie, Ontario, Canada
- Toronto, Ontario, Canada
+ 45 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 130 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Los Angeles, California, United States; Washington D.C., District of Columbia, United States; Chicago, Illinois, United States; Baltimore, Maryland, United States; Boston, Massachusetts, United States and 59 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.