Colorectal CancerPhase 2NCT06205836
Cemiplimab With or Without Fianlimab to Treat Older Patients With Localized or Locally Advanced MSI-H Colorectal Cancer
A Phase 2 study testing Cemiplimab and Fianlimab in people with Colorectal Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Cemiplimab and Fianlimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2024to May 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Must be agreeable to endoscopic, and CT surveillance for a total of 24 months.
- Patient's acceptance to have a tumor biopsy.
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- Patients must have adequate organ and marrow function defined by study-specified laboratory tests and procedures.
- LVEF assessment with documented LVEF ≥ 45% by either TTE or MUGA (TTE preferred) within 6 months from first study drug administration.
- For both Women and Men, must use acceptable form of birth control while on study.
- Ability to understand and willingness to sign a written informed consent document.
- Age ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 -3.
- Have histologically proven localized or locally advanced mismatch repair deficient (dMMR) or microsatellite unstable (MSI-H) colorectal cancer.
- Patient deemed a poor surgical candidate after evaluation by a surgeon or unwilling to undergo surgery.
- Must not have received any prior systemic treatment or radiation.
- Must be agreeable to endoscopic, and CT surveillance for a total of 24 months.
- Patient's acceptance to have a tumor biopsy.
- Patients must have adequate organ and marrow function defined by study-specified laboratory tests and procedures.
- For both Women and Men, must use acceptable form of birth control while on study.
- Ability to understand and willingness to sign a written informed consent document.
Who cannot join
- 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.
- Currently using any chronic systemic steroids.
- Patient has received a live vaccine within 30 days of the first dose of study drug.
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- History of severe hypersensitivity reaction to any monoclonal antibody.
- Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness/social situations that would limit compliance with study requirements.
- Active autoimmune disease.
- Any tissue or organ allograft, regardless of need for immunosuppression, including corneal allograft.
- Patient has a pulse oximetry of <92% on room air.
- Patient is on supplemental home oxygen.
- Has clinically significant heart disease.
- Cohort B Only: Troponin T (TnT) or troponin I (TnI) > 2x institutional ULN at baseline.
- Conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures.
- Unwilling or unable to follow the study schedule for any reason
- 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.
- Currently using any chronic systemic steroids.
- Patient has received a live vaccine within 30 days of the first dose of study drug.
- History of severe hypersensitivity reaction to any monoclonal antibody.
- Any tissue or organ allograft, regardless of need for immunosuppression, including corneal allograft.
- Patient is pregnant or breastfeeding.
- Cohort D Only: Troponin T (TnT) or troponin I (TnI) > 2x institutional ULN at baseline.
- Conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures.
- Participation deemed not in the best interest of the patient.
- Unwilling or unable to follow the study schedule for any reason.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins SKCCC
Baltimore, Maryland, 21231
Colleen Apostol, RN, 410-614-3644, GIClinicalTrials@jhmi.edu
Eric Christenson, MD
About this study
Official title: Evaluating a Surgical-Sparing Approach Using Cemiplimab With or Without Fianlimab to Treat Older Patients With Localized or Locally Advanced MSI-H Colorectal Cancer
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.
- Conditions
- Colorectal Cancer
- Being tested
- Cemiplimab, Fianlimab
- Keywords
- Colorectal Cancer, Cemiplimab, Fianlimab, Immunotherapy, Anti-PD-1 therapy, Anti-Lag-3, Adenocarcinoma, Carcinoma
- Medical subject headings
- Colorectal Neoplasms, Adenocarcinoma, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CemiplimabDrug
Also called REGN2810, LIBTAYO
Patients will receive cemiplimab (350 mg administered IV) on Day 1 of each 21 day cycle for a total of 4 cycles of treatment.
FianlimabDrug
Also called REGN3767
Patients will receive fianlimab (1600 mg administered IV) on Day 1 of each 21 day cycle for a total of 4 cycles of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A - Cemiplimab | Experimental | Not described Receives: Drug: Cemiplimab |
| Cohort B - Cemiplimab with Fianlimab | Experimental | Not described Receives: Drug: Cemiplimab; Drug: Fianlimab |
| Cohort C - Cemiplimab | Experimental | Not described Receives: Drug: Cemiplimab |
| Cohort D - Cemiplimab with Fianlimab | Experimental | Not described Receives: Drug: Cemiplimab; Drug: Fianlimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 7 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start13 Jun 2024
- Primary completionMay 2030 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Eric Christenson, MD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Medical Institution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06205836
- Sponsor's protocol ID
- J23155
- Other IDs
- IRB00415816
- Status last verified
- May 2026
- First submitted
- 4 Jan 2024
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Surgical-Sparing Approach Using Cemiplimab With or Without Fianlimab to Treat Older Patients With Localized or Locally Advanced MSI-H Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06205836
- Acronym / sponsor ID
- J23155
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal Cancer, Cemiplimab, Fianlimab, Immunotherapy, Anti-PD-1 therapy, Anti-Lag-3, Adenocarcinoma, Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 13 Jun 2024 (actual)
- Primary completion
- May 2030 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 16 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort A - Cemiplimab | Experimental | Drug: Cemiplimab |
| Cohort B - Cemiplimab with Fianlimab | Experimental | Drug: Cemiplimab, Drug: Fianlimab |
| Cohort C - Cemiplimab | Experimental | Drug: Cemiplimab |
| Cohort D - Cemiplimab with Fianlimab | Experimental | Drug: Cemiplimab, Drug: Fianlimab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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.
- Must be agreeable to endoscopic, and CT surveillance for a total of 24 months.
Key exclusion criteria (27 listed)
- 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.
- Currently using any chronic systemic steroids.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CemiplimabAlso: REGN2810, LIBTAYOPatients will receive cemiplimab (350 mg administered IV) on Day 1 of each 21 day cycle for a total of 4 cycles of treatment. | Drug | Cohort A - Cemiplimab, Cohort B - Cemiplimab with Fianlimab, Cohort C - Cemiplimab, Cohort D - Cemiplimab with Fianlimab |
| FianlimabAlso: REGN3767Patients will receive fianlimab (1600 mg administered IV) on Day 1 of each 21 day cycle for a total of 4 cycles of treatment. | Drug | Cohort B - Cemiplimab with Fianlimab, Cohort D - Cemiplimab with Fianlimab |
Primary outcome
Complete Response Rate
Time frame: 6 Months
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.
1 secondary outcome
Number of participants experiencing grade 3 or above drug-related toxicities requiring treatment discontinuation
Time frame: 7 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eric Christenson, MD principal investigator
Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Medical Institution
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cemiplimab and Fianlimab in people with Colorectal Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Colleen Apostal, RN (410-614-3644, GIClinicalTrials@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response Rate (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.