Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06205836 · ClinicalTrials.gov registry record · Phase 2
Cemiplimab With or Without Fianlimab to Treat Older Patients With Localized or Locally Advanced MSI-H Colorectal Cancer
A Phase 2 study of Colorectal Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 44
- Enrollment target
- 1
- Study location
NCT06205836: Recruiting Phase 2 study of Colorectal Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT06205836 is a Phase 2 study of Colorectal Cancer that is actively recruiting participants, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 44 participants, below the 1,545-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06205836, a Phase 2 study of Colorectal Cancer, is actively recruiting participants, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 44 participants
- Enrollment target
- 1
- Study location
Study 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 or unwilling to undergo surgery.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Cemiplimab
- DRUG Fianlimab
Study Locations (1)
Maryland
- Johns Hopkins SKCCC - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2024-06-13 |
| Est. Completion | 2028-05 |
| Phase | Phase 2 |
What NCT06205836 shows while recruiting
NCT06205836 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 1,545-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Colorectal Cancer appearing as the primary indexed condition, and to 2 interventions - of which Cemiplimab is the first listed.
NCT06205836 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT06205836 about?
NCT06205836 is a clinical study titled "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 cand...
What is the current status of trial NCT06205836?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2024-06-13. Estimated completion is 2028-05.
What conditions does trial NCT06205836 study?
This clinical trial studies the following conditions: Colorectal Cancer.
What interventions are being tested in trial NCT06205836?
The interventions under investigation include: Cemiplimab (DRUG), Fianlimab (DRUG).
Who is sponsoring clinical trial NCT06205836?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06205836 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Colorectal Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06205836's enrollment target sits among peer trials
44 287th of 381 higher than 92 of 381 other Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study to Assess Adverse Events and Change in Disease Activity in Adult Participants Receiving Intravenously Infused Telisotuzumab Adizutecan Alone or With Standard of Care in Participants With Post Adjuvant Circulating Tumor DNA Positive Colorectal Cancer and No Radiographic Evidence of Disease
RECRUITING · Phase 2
-
A Study of Single Fraction Stereotactic Body Radiation Therapy (SBRT) Guided by Magnetic Resonance Imaging (MRI) in People With Liver Metastasis From Colorectal Cancer
RECRUITING · Phase 2
-
TAS-102 With or Without Celecoxib in ctDNA-defined Minimal Residual Disease in Colorectal Cancer After Completion of Adjuvant Chemotherapy
RECRUITING · Phase 2
-
A Phase 2 Trial of Fruquintinib and Tislelizumab in ctDNA-defined Minimal Residual Disease in Colorectal Cancer After Completion of Adjuvant Chemotherapy
RECRUITING · Phase 2
-
A Study of IBI363 in Subjects with Advanced Solid Malignancies
RECRUITING · Phase 2
-
Repurposing Riluzole for Cancer-Related Cognitive Impairment: A Pilot Trial
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02323945 · 44 participants · NA
Effects of Breathing Mild Bouts of Low Oxygen on Limb Mobility After Spinal Injury
- NCT03093909 · 44 participants · Phase 1
Study of Aerosol Gemcitabine in Patients With Solid Tumors and Pulmonary Metastases
- NCT03104491 · 44 participants · Phase 1
Inotuzumab Ozogamicin Post-Transplant For Acute Lymphocytic Leukemia
- NCT03781765 · 44 participants · Phase 4
Stimulant vs. Non-stimulant Treatments and Reward Processing in Drug-naive Youth at SUD Risk
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI