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Cemiplimab With or Without Fianlimab to Treat Older Patients With Localized or Locally Advanced MSI-H Colorectal Cancer

ConditionColorectal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins

About this trial

The purpose of this study is to evaluate the safety and clinical activity of cemiplimab and the combination of cemiplimab/fianlimab in microsatellite unstable localized or locally advanced colorectal cancer diagnosed in patients age 70 or greater or in patients age 18 or greater considered poor candidates for surgery or unwilling to undergo surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥70 years.

Eastern Cooperative Oncology Group (ECOG) performance status 0 -2

Have histologically proven localized or locally advanced mismatch repair deficient (dMMR) or microsatellite unstable (MSI-H) colorectal cancer.

Must not have received any prior systemic treatment or radiation.

Disqualifiers

Have received an investigational agent or used an investigational device within 28 days of the first dose of study drug.

Have expected to require any other form of systemic or localized antineoplastic therapy while on study.

Have had surgery within 28 days of dosing of investigational agent, excluding minor procedures (dental work, skin biopsy, etc.).

History of prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, or anti-Lag-3 antibodies for any reason in the 5 years proceeding their colorectal cancer diagnosis.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cemiplimab

    Drug

    Patients will receive cemiplimab (350 mg administered IV) on Day 1 of each 21 day cycle for a total of 4 cycles of treatment.

  • Fianlimab

    Drug

    Patients will receive fianlimab (1600 mg administered IV) on Day 1 of each 21 day cycle for a total of 4 cycles of treatment.

Treatment groups

44 Participants
are divided into 4 treatment groups
Group A: Cohort A - CemiplimabExperimental treatment 1 intervention
Group B: Cohort B - Cemiplimab with FianlimabExperimental treatment 2 interventions
Group C: Cohort C - CemiplimabExperimental treatment 1 intervention
Group D: Cohort D - Cemiplimab with FianlimabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Complete Response Rate

Proportion of subjects with either a pathologic complete response (pCR) at the time of surgery OR a clinical complete response (cCR) at 6 months for those subjects who do not undergo surgery. pCR is defined as subjects with no viable tumor cell noted on pathological evaluation of the resection specimen. cCR is defined as an absence of visible disease on CT imaging by RECIST 1.1 and endoscopic evaluation.

Time frame
6 Months

Secondary outcomes

1

Number of participants experiencing grade 3 or above drug-related toxicities requiring treatment discontinuation

Defined using NCI CTCAE v5.0

Time frame
7 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead sponsor

Regeneron Pharmaceuticals

Collaborator

Source ClinicalTrials.gov
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