Montvale, NJNCT07927998Now EnrollingIRB Ready

Anal Squamous Cell Carcinoma Clinical Trial in Montvale, NJ

Access cutting-edge anal squamous cell carcinoma treatment through this phase 2 clinical trial at a research site in Montvale. Study-provided care at no cost to qualified participants.

Sponsored by Memorial Sloan Kettering Cancer Center

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Expert Care in Montvale

Access anal squamous cell carcinoma specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related anal squamous cell carcinoma treatment provided free

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Check if you qualify for this anal squamous cell carcinoma clinical trial in Montvale, NJ

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Why Participate?

  • No-Cost Study Care

  • Local to Montvale

    Convenient for NJ residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Montvale site if eligible
  4. 4Begin participation

About This Anal Squamous Cell Carcinoma Study in Montvale

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.

Sponsor: Memorial Sloan Kettering Cancer Center

Who Can Participate

Inclusion 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
Patients must have MRD after completion of definitive-CRT defined as:
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. The ACT II trial demonstrated that 70% of patients with an incomplete response to CRT at 3-months achieved a clinical complete response by 6-months \[18\].
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 toxicities considered clinically nonsignificant and/or stable on supportive therapy as determined by the investigator. o Lymphopenia is a known side effect of CRT, which can take months to resolve \[4\], and is not an

Exclusion Criteria

to eligibility.
ECOG Performance Status of ≤ 2
Required Organ Function
Adequate hematologic function defined as follows:
Absolute neutrophil count (ANC) ≥= 1,000 cells/mm3
Platelets ≥ 75,000 cells/mm3
Hemoglobin ≥ 9 g/dl
Adequate renal function defined as follows:
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 creatinine clearance should be ≥30 mL/min.): CrCl (mL/min) = \[ (140 - Age) × Weight (kg)\] / \[72 × Serum Creatinine (mg/dL)\], multiplied by 0.85 for females.
Adequate hepatic function defined as follows:
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
Adequate cardiac function defined as follows:
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 Functional Classification.
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). Exclusion Criteria:
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. o Participants of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) during study therapy and for 6 months following the completion of study therapy.
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. Patients who are receiving or who have received anti-HBV therapy and have undetectable HBV DNA prior to study entry are eligible.
Known active hepatitis C virus (HCV) as determined by positive serology and confirmed by polymerase chain reaction (PCR). Patients on or who have received antiretroviral therapy are eligible provided they are virus-free by PCR for at least 6 months prior to study entry.
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, BCG, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live-attenuated vaccines and are not allowed.
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).

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Montvale?

Yes, this clinical trial (NCT07927998) has an active research site in Montvale, NJ that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Anal Squamous Cell Carcinoma Treatment Options in Montvale, NJ

If you're searching for anal squamous cell carcinoma treatment options in Montvale, NJ, this clinical trial (NCT07927998) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Montvale research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced anal squamous cell carcinoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

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