Anal Squamous Cell Carcinoma study: Retifanlimab
Official title A Study of Retifanlimab After Chemoradiation in People With Anal Cancer
ClinicalTrials.gov ID: NCT07927998
What this study is testing
What is Retifanlimab?
Retifanlimab is an investigational medicine, given as an IV infusion (through a vein), being studied as a potential treatment for anal squamous cell carcinoma.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- people 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Subject or legally authorized representative is willing and able to provide written informed consent.
- Age ≥ 18 on day of signing informed consent.
- 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.
- Disease Specific Criteria
You likely can't join if
- 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...
- Interstitial lung disease or active noninfectious pneumonitis.
See the full eligibility criteria
- Subject or legally authorized representative is willing and able to provide written informed consent.
- Age ≥ 18 on day of signing informed consent.
- 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
- Detectable on the last day of or after completing definitive-CRT.
- In patients with MRD within 6 months of CRT completion, patients with no overt clinical or radiographic progression will be eligible, the treatment response evolves for up to 6-months after completion of CRT.
- ctDNA will be assessed using Natera Signatera, a CLIA- validated tumor informed ctDNA assay, which MSK patients currently undergo baseline, on-treatment, and surveillance monitoring as standard of care.
- As patients will not have measurable radiographic disease at time of enrollment, RECIST will not be used for study.
- Patients must sign informed consent within 4 weeks of positive ctDNA result. The 4 weeks is considered from the date that the ctDNA resulted, and not the date it is drawn.
- Patients must have completed definitive CRT per institutional standards or as determined appropriate by the principal investigator.
- Resolution of all non-hematologic toxicities of prior therapy or surgical procedures to baseline or Grade 1 (except for hypothyroidism requiring medication, which must have resolved to Grade ≤2), alopecia, and other...
- ECOG Performance Status of ≤ 2
- Required Organ Function
- Absolute neutrophil count (ANC) ≥= 1,000 cells/mm3
- Platelets ≥ 75,000 cells/mm3
- Hemoglobin ≥ 9 g/dl
- Creatinine clearance (CrCL) of ≥30 mL/min by the Cockcroft-Gault formula (Note: For agents for which renal excretion is not a major route of clearance and for which renal toxicity is not an issue, the threshold for...
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x ULN may be enrolled)
- AST and ALT ≤2.5 x institutional ULN
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association...
- To be eligible for this trial, patients with known congestive heart failure should be class 2B or better (see Appendix II: New York Heart Association (NYHA) Functional Classification).
- 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.
- History of allogeneic bone marrow/stem, cell, or solid organ transplant.
- Pregnant or nursing or expecting to conceive or father children within the projected duration of the trial.
- Uncontrolled infection with human immunodeficiency virus (HIV). HIV-infected patients on effective anti-retroviral therapy with undetectable viral load and CD4+ count \>300/μL within 6 months are eligible.
- Known to be hepatitis B virus (HBV) surface antigen, or any other positive test for HBV indicating acute or chronic infection.
- Known active hepatitis C virus (HCV) as determined by positive serology and confirmed by polymerase chain reaction (PCR).
- Receipt of a live vaccine within 28 days of planned start of study drug. Note: Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox/zoster, yellow fever, rabies...
- Prior therapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 agent.
- History of allergic reaction to the study agent(s), compounds of similar chemical or biologic composition to the study agent (s) (or any of its excipients).
The study team makes the final eligibility decision.
Where it is enrolling
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Rockville Centre, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.