Active — Not RecruitingPhase 1/2

COLUMBIA-1: Novel Oncology Therapies in Combination With Chemotherapy and Bevacizumab as First- Line Therapy in MSS-CRC

United States, Australia, Canada61 participantsStarted 2019-09-13

Plain-language summary

COLUMBIA-1 is a Phase 1b/2 platform study to evaluate the safety and efficacy of standard of care (FOLFOX plus bevacizumab) alone and in combination with novel oncology therapies in first-line metastatic microsatellite-stable colorectal cancer (MSS-CRC).

Who can participate

Age range

18 Years – 101 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Written informed consent and any locally required authorization obtained from the participant/legal representative prior to performing any protocol-related procedures, including screening evaluations.
. Age ≥ 18 years at the time of screening.
. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
. Participants must have histologic documentation of advanced or metastatic CRC and: (a) A documented mutation test during screening and confirmed tumor locations from disease assessment for enrollment. (b) Participants must NOT have defective deoxyribonucleic acid (DNA) mismatch repair (MSI) as documented by testing. (c) Participants must not have received any prior systemic therapy for recurrent/metastatic disease (prior adjuvant chemotherapy or radio-chemotherapy is acceptable so long as progression was not within 6 months of completing the adjuvant regimen).
. Participants must have at least one lesion that is measurable by RECIST v1.1 (Eisenhauer et al, 2009).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) in Part 1

Timeframe: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years)

Number of Participants With Dose Limiting Toxicities (DLTs) in Part 1

Timeframe: From Day 1 to 28 days after the first dose of novel oncology therapy (durvalumab and oleclumab)

Number of Participants With at Least 2-Grade Shift From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters in Part 1

Timeframe: Baseline (Day 1) through 90 days after the last dose of study drug (approximately 2.8 years)

Number of Participants With Abnormal Vital Signs Reported as TEAEs in Part 1

Timeframe: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years)

Percentage of Participants With Objective Response (OR) Per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) in Part 2

Timeframe: Randomization through end of study (approximately 2.6 years)

Trial details

NCT IDNCT04068610

SponsorMedImmune LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-10-10

Results submitted2023-10-06

View on ClinicalTrials.gov More Metastatic Microsatellite-stable Colorectal Cancer trials