EA2176: Phase 3 Clinical Trial of Carboplatin and Paclitaxel +/- Nivolumab in Metastatic Anal Cancer Patients (NCT04444921)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Patient must have inoperable, recurrent, or metastatic disease not amenable to curative therapy
2. Patient must have histological or cytological confirmation of anal squamous cell carcinoma (includes basaloid and cloacogenic lesions) from the primary tumor or a newly diagnosed recurrent/metastatic lesion
3. Patient must be \>= 18 years of age
4. Patient must have Eastern Cooperative Oncology Group (ECOG) performance status =\< 0-1
5. Patients must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 and based on radiologic assessment performed \< 4 weeks prior to randomization
6. Patient receiving palliative (limited-field) radiation therapy is allowed, as long as the lesion treated for palliation is not a target lesion and is \> 7 days from completion from palliative radiation
7. Patients with brain metastasis are eligible if patient is asymptomatic and if treatment ended \> 3 months prior to randomization. Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression within 4 weeks prior to randomization
8. Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study with a minimum sensitivity of 25 IU/L or equivalent units of Bacille Calmette-Guerin (BCG), within 14 days prior to randomization to rule out pregnancy. A patient of childbearing potential is defined as anyone, regardless of whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
9. Patients of childbearing potential must not expect to conceive children by using accepted and effective method(s) of contraception or to abstain from sexual intercourse for at least one week prior to the start of treatment, and continue for 5 months after the last dose of protocol treatment
10. Absolute neutrophil count \>= 1,500/mcL (obtained \< 14 days prior to randomization)
11. Platelets \>= 100,000/mcL (obtained \< 14 days prior to randomization)
12. Hemoglobin (Hgb) \>= 9 g/dL for males and \>= 9 g/dL for females (obtained \< 14 days prior to randomization)

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (579 Sites)

• Anchorage Associates in Radiation Medicine — Anchorage, Alaska
• Anchorage Radiation Therapy Center — Anchorage, Alaska
• Alaska Breast Care and Surgery LLC — Anchorage, Alaska
• Alaska Oncology and Hematology LLC — Anchorage, Alaska
• Alaska Women's Cancer Care — Anchorage, Alaska
• Anchorage Oncology Centre — Anchorage, Alaska
• Katmai Oncology Group — Anchorage, Alaska
• Providence Alaska Medical Center — Anchorage, Alaska
• Kingman Regional Medical Center — Kingman, Arizona
• Cancer Center at Saint Joseph's — Phoenix, Arizona
• Mercy Hospital Fort Smith — Fort Smith, Arkansas
• CHI Saint Vincent Cancer Center Hot Springs — Hot Springs, Arkansas
• Kaiser Permanente-Anaheim — Anaheim, California
• Kaiser Permanente-Deer Valley Medical Center — Antioch, California
• Mission Hope Medical Oncology - Arroyo Grande — Arroyo Grande, California
• PCR Oncology — Arroyo Grande, California
• Kaiser Permanente-Baldwin Park — Baldwin Park, California
• Kaiser Permanente-Bellflower — Bellflower, California
• Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California
• Kaiser Permanente Dublin — Dublin, California
• Kaiser Permanente-Fontana — Fontana, California
• Kaiser Permanente-Fremont — Fremont, California
• Fresno Cancer Center — Fresno, California
• Kaiser Permanente-Fresno — Fresno, California
• Kaiser Permanente South Bay — Harbor City, California

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.