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Part 1 (S1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab for Colorectal Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by MedImmune LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assignment through end of study (approximately 2.8 years)
Awards & highlights

Study Summary

This trial is testing new cancer treatments in people with a certain kind of colon cancer.

Eligible Conditions
  • Metastatic Microsatellite Stable Colorectal Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assignment through end of study (approximately 2.8 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and assignment through end of study (approximately 2.8 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Abnormal Vital Signs Reported as TEAEs in Part 1
Number of Participants With Dose Limiting Toxicities (DLTs) in Part 1
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) in Part 1
+2 more
Secondary outcome measures
BOR Per RECIST v1.1 in Part 2
Best Overall Response (BOR) Per RECIST v1.1 in Part 1
DoR Per RECIST v1.1 in Part 2
+19 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Part 2 (E1): FOLFOX + Bevacizumab + Durvalumab + OleclumabExperimental Treatment4 Interventions
Participants in Part 2 experimental 1 arm (E1) will receive IV infusions of FOLFOX (5-FU: 2400 mg/m^2 over 46-48 hours [Day 1 and 2 of every 14-day Cycle], oxaliplatin: 85 mg/m^2, folinic acid: 400 mg/m^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg Q4W and IV oleclumab 3000 mg Q2W till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion will be met.
Group II: Part 2 (C1): FOLFOX + BevacizumabExperimental Treatment2 Interventions
Participants in Part 2 control 1 arm (C1) will receive IV infusions of FOLFOX (5-FU: 2400 mg/m^2 over 46-48 hours [Day 1 and 2 of every 14-day Cycle], oxaliplatin: 85 mg/m^2, folinic acid: 400 mg/m^2) in combination with IV bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion will be met.
Group III: Part 1 (S1): FOLFOX + Bevacizumab + Durvalumab + OleclumabExperimental Treatment4 Interventions
Participants in Part 1 safety run-in arm (S1) will receive intravenous (IV) infusions of FOLFOX (5-fluorouracil [5-FU]: 2400 mg/m^2 over 46-48 hours [Day 1 and 2 of every 14-day Cycle], oxaliplatin: 85 mg/m^2, folinic acid: 400 mg/m^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg every 4 weeks (Q4W) and IV oleclumab 3000 mg every 2 weeks (Q2W) till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion will be met.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oleclumab
2015
Completed Phase 2
~880
Durvalumab
2017
Completed Phase 2
~3870
Bevacizumab
2013
Completed Phase 4
~5280
FOLFOX
2009
Completed Phase 3
~4560

Find a Location

Who is running the clinical trial?

MedImmune LLCLead Sponsor
347 Previous Clinical Trials
793,848 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial permit individuals who are septuagenarian or older to participate?

"Participants of this medical study must be 18 years or older, and under 101."

Answered by AI

What other investigations have been conducted exploring the effects of Experimental?

"Currently, 1135 studies centred on Experimental are active. Of these trials, 301 have reached the Phase 3 stage. The majority of these medical experiments have been conducted in Guangzhou, Guangdong; however, there exist 48 862 sites running trials for this treatment."

Answered by AI

How many centers are responsible for the management of this medical experiment?

"At present, there are 16 clinical sites running this trial. These include Edmonton, Philadelphia and Sacramento in addition to other cities. To minimize any travel burden that may be associated with enrolling, participants should consider selecting the closest clinic to them."

Answered by AI

Are there any open enrollment slots for this study at the moment?

"This study is no longer obtaining participants. The trial was first posted on September 13th 2019 and the most recent update occurred in October 31st 2022. If you are interested in other research, 856 clinical trials are actively recruiting patients with colorectal carcinoma while 1135 studies remain open for Experimental drug testing enrolment."

Answered by AI

Do I meet the criteria to partake in this investigation?

"This clinical trial has opened their recruitment for 61 patients between 18 and 101 years of age, suffering from colorectal carcinoma. In addition to the requirements based on age, applicants must have adequate organ function, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, a documented mutation test during screening with confirmed tumor locations from disease assessment, no defective DNA mismatch repair (MSI), not received any prior systemic therapy within 6 months of completing adjuvant regimen., at least one lesion that is measurable by RECIST v1.1 and if they are taking anticoagulant medication it must"

Answered by AI

What medical conditions is the drug Experimental typically prescribed to treat?

"Experimental is frequently used to treat locally advanced cases of nonsquamous non-small cell lung cancer and can also be prescribed for metastatic colorectal cancer, advanced gastric cancer, and other non-immunocompromised conditions."

Answered by AI

What benefits are the researchers attempting to demonstrate through this clinical trial?

"The main purpose of this investigation is to measure the antitumor activity of FOLFOX plus bevacizumab plus novel oncology therapy combinations versus FOLFOX plus bevacizumab through a 28 day period in part 1, and an OR rate as recorded during part 2. Safety will also be monitored by assessing clinically significant laboratory values. Additional secondary objectives include measuring efficacy with DCR (defined as confirmed CR, confirmed PR or SD) based on RECIST v1.1, as well evaluating DoR (the duration from first documentation of response until progression or death due to any cause)."

Answered by AI

How many participants has this research project recruited thus far?

"This particular trial is not accepting participants at the moment. It was initially listed on September 13th 2019 and last updated October 31st 2022, so it may open up again in due time. There are 856 studies which seek enrolment from colorectal carcinoma patients and 1135 experiments that require volunteers now."

Answered by AI
~11 spots leftby Apr 2025