Program Status
RecruitingPhase
Phase 2Prior Immunotherapy Allowed
NoCRC-directed Trial
YesTags
MSS/ MMRpComments
No liver mets allowed, no prior tx in the mestastatic setting. Bispecific immunotherapy MEDI5752 (anti PD-1 plus anti CTLA4)
Randomized. Volrustomig + FOLFIRI+ Bevacizumab vs FOLFIRI+ Bevacizumab (SOC)
Helpful Links
| Location | Location Status |
|---|---|
| United States | |
|
Research Site Scottsdale, Arizona 85259 |
Not yet recruiting |
|
Research Site Los Angeles, California 90089 |
Not yet recruiting |
|
Research Site Washington, District of Columbia 20007 |
Not yet recruiting |
|
Research Site Chicago, Illinois 60637 |
Not yet recruiting |
|
Research Site Baltimore, Maryland 21224 |
Not yet recruiting |
|
Research Site Boston, Massachusetts 02114 |
Not yet recruiting |
|
Research Site Rochester, Minnesota 55905 |
Not yet recruiting |
|
Research Site Rochester, New York 14618 |
Not yet recruiting |
|
Research Site Cleveland, Ohio 44106 |
Not yet recruiting |
|
Research Site Houston, Texas 77030 |
Not yet recruiting |
| Australia | |
|
Research Site East Melbourne 3002 |
Not yet recruiting |
|
Research Site Wollongong 2500 |
Not yet recruiting |
| Canada | |
|
Research Site Victoria, British Columbia V8R 6V5 |
Not yet recruiting |
|
Research Site Barrie, Ontario L4M 6M2 |
Not yet recruiting |
|
Research Site Toronto, Ontario M5G 1X6 |
Not yet recruiting |
|
Research Site Montreal, Quebec H3T 1E2 |
Not yet recruiting |
| China | |
|
Research Site Beijing 100142 |
Not yet recruiting |
|
Research Site Harbin 150081 |
Not yet recruiting |
|
Research Site Shanghai 200032 |
Not yet recruiting |
|
Research Site Zhengzhou City 450000 |
Not yet recruiting |
| France | |
|
Research Site Bordeaux 33076 |
Not yet recruiting |
|
Research Site Montpellier 34090 |
Not yet recruiting |
|
Research Site Montpellier 34298 |
Not yet recruiting |
|
Research Site Poitiers 86021 |
Not yet recruiting |
|
Research Site Saint-Priez En Jarez 42270 |
Not yet recruiting |
|
Research Site Villejuif Cedex 94805 |
Not yet recruiting |
| Germany | |
|
Research Site Berlin 10117 |
Not yet recruiting |
|
Research Site Dresden 01307 |
Not yet recruiting |
|
Research Site Essen 45147 |
Not yet recruiting |
|
Research Site Hamburg 22763 |
Not yet recruiting |
|
Research Site Marburg 35043 |
Not yet recruiting |
| Italy | |
|
Research Site Firenze 50134 |
Not yet recruiting |
|
Research Site Milano 20133 |
Not yet recruiting |
|
Research Site Milano 20162 |
Not yet recruiting |
|
Research Site Napoli 80131 |
Not yet recruiting |
|
Research Site Pavia 27100 |
Not yet recruiting |
|
Research Site Roma 00168 |
Not yet recruiting |
| Korea, Republic of | |
|
Research Site Seoul 03080 |
Recruiting |
|
Research Site Seoul 06351 |
Recruiting |
|
Research Site Seoul 06591 |
Not yet recruiting |
|
Research Site Seoul 5505 |
Not yet recruiting |
|
Research Site Yongin-si 16995 |
Not yet recruiting |
| Spain | |
|
Research Site Barcelona 08035 |
Not yet recruiting |
|
Research Site Madrid 28007 |
Not yet recruiting |
|
Research Site Madrid 28034 |
Not yet recruiting |
|
Research Site Madrid 28041 |
Not yet recruiting |
|
Research Site Malaga 29010 |
Not yet recruiting |
|
Research Site Pamplona 31005 |
Not yet recruiting |
|
Research Site Santander 39008 |
Not yet recruiting |
|
Research Site València 46010 |
Not yet recruiting |
| Taiwan | |
|
Research Site Kaohsiung 80756 |
Recruiting |
|
Research Site Taipei 10002 |
Not yet recruiting |
|
Research Site Taoyuan 333 |
Not yet recruiting |
|
Research Site Yung Kang City 71044 |
Not yet recruiting |
| United Kingdom | |
|
Research Site Cambridge CB2 0XY |
Not yet recruiting |
|
Research Site London NW1 2PG |
Not yet recruiting |
|
Research Site London W12 0HS |
Not yet recruiting |
|
Research Site Manchester M20 4GJ |
Not yet recruiting |
|
Research Site Wirral CH63 4JY |
Not yet recruiting |
Contacts
CONTACT
1-877-240-9479 information.center@astrazeneca.com
Inclusion 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
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.
