Phase 2: testing Retifanlimab for Anal Squamous Cell Carcinoma
Participants will receive retifanlimab during 28-day treatment Cycles and will continue to receive retifanlimab for up to 6 Cycles (up to 12 Cycles with study doctor approval) unless the participant's cancer comes back, have serious side effects and cannot continue study treatment, or the study doctor thinks it is in the participant's best interest to stop.
Official registry: https://clinicaltrials.gov/study/NCT07927998 · Memorial Sloan Kettering Cancer Center · enrollment listed as 25
What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Retifanlimab. The registry lists allocation as na. Participants will receive retifanlimab during 28-day treatment Cycles and will continue to receive retifanlimab for up to 6 Cycles (up to 12 Cycles with study doctor approval) unless the participant's cancer comes back, have serious side effects and cannot continue study treatment, or the study doctor thinks it is in the participant's best interest to stop.
They plan to enroll about 25 people at 7 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
A Phase II Trial Evaluating Personalized Anal Squamous Cell Carcinoma Treatment Escalation Using Real-Time ctDNA Surveillance (PACER)
Interventions: Retifanlimab
Primary outcome (registry wording): Rate of ctDNA clearance at 12 weeks
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- Consent for use of archival tissue and blood draws for research purposes
- Documentation of Disease
- o Patients must have pathologically confirmed anal squamous cell carcinoma
- ° Pathology confirmation of the primary tumor at time of initial diagnosis is acceptable
- Disease Specific Criteria
- Patients must have MRD after completion of definitive-CRT defined as:
- Detectable on the last day of or after completing definitive-CRT
Who the registry excludes
- Presence of metastatic or recurrent disease
- Active infection requiring parenteral antibiotic(s)
- Known active TB (Bacillus tuberculosis) infection
- Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
- Active immune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (\>10mg of prednisone or equivalent)
- Interstitial lung disease or active noninfectious pneumonitis
- Known active CNS metastases and/or carcinomatous meningitis
Public study contact (from the registry)
Paul Romesser, MD
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
7 listed- Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey (recruiting)
- Memorial Sloan Kettering Monmouth (Limited protocol activities) — Middletown, New Jersey (recruiting)
- Memorial Sloan Kettering Bergen (Limited protocol activities) — Montvale, New Jersey (recruiting)
- Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) — Commack, New York (recruiting)
- Memorial Sloan Kettering Westchester (All protocol activities) — Harrison, New York (recruiting)
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York (recruiting)
- Memorial Sloan Kettering Nassau (Limited protocol activities) — Rockville Centre, New York (recruiting)
FAQ about this NCT record
Is NCT07927998 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07927998?
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07927998?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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