NCT02314169

Nivolumab With or Without Ipilimumab in Treating Patients With Refractory Metastatic Anal Canal Cancer

Active, enrolled Phase 2 Last updated 29 April 2025

What this trial tests

Phase 2 trial testing Biospecimen Collection in Anal Canal Squamous Cell Carcinoma in 37 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

13 May 2015

Primary endpoint
15 February 2025

21 March 2026

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	37
Start date	13 May 2015
Primary completion	15 February 2025
Estimated completion	21 March 2026
Sites	56 locations across Canada, United States

Drugs / interventions tested

• Biospecimen Collection — full drug profile →
• Computed Tomography
• Ipilimumab — full drug profile →
• Magnetic Resonance Imaging
• Nivolumab (nivolumab) — full drug profile →

Conditions studied

• Anal Canal Squamous Cell Carcinoma — all drugs for Anal Canal Squamous Cell Carcinoma →
• Metastatic Anal Canal Carcinoma — all drugs for Metastatic Anal Canal Carcinoma →
• Stage IV Anal Cancer AJCC v8 — all drugs for Stage IV Anal Cancer AJCC v8 →

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, any sex, with Anal Canal Squamous Cell Carcinoma or Metastatic Anal Canal Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase II trial studies how well nivolumab with or without ipilimumab works in treating patients with anal canal cancer that has not responded to previous treatment (refractory) and that has spread from where it first started (primary site) to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Nivolumab for previously treated unresectable metastatic anal cancer (NCI9673): a multicentre, single-arm, phase 2 study.
   Morris VK, Salem ME, Nimeiri H, Iqbal S, et al · · 2017 · cited 284× · PMID 28223062 · DOI 10.1016/s1470-2045(17)30104-3
2. Modernizing Clinical Trial Eligibility Criteria: Recommendations of the American Society of Clinical Oncology-Friends of Cancer Research HIV Working Group.
   Uldrick TS, Ison G, Rudek MA, Noy A, et al · · 2017 · cited 135× · PMID 28968173 · DOI 10.1200/jco.2017.73.7338
3. PD-1/PD-L blockade in gastrointestinal cancers: lessons learned and the road toward precision immunotherapy.
   Long J, Lin J, Wang A, Wu L, et al · · 2017 · cited 77× · PMID 28774337 · DOI 10.1186/s13045-017-0511-2
4. Association of HIV Status With Local Immune Response to Anal Squamous Cell Carcinoma: Implications for Immunotherapy.
   Yanik EL, Kaunitz GJ, Cottrell TR, Succaria F, et al · · 2017 · cited 63× · PMID 28334399 · DOI 10.1001/jamaoncol.2017.0115
5. Human papillomavirus in the setting of immunodeficiency: Pathogenesis and the emergence of next-generation therapies to reduce the high associated cancer risk.
   Hewavisenti RV, Arena J, Ahlenstiel CL, Sasson SC. · · 2023 · cited 57× · PMID 36960048 · DOI 10.3389/fimmu.2023.1112513
6. Trial watch: Immune checkpoint blockers for cancer therapy.
   Vanpouille-Box C, Lhuillier C, Bezu L, Aranda F, et al · · 2017 · cited 55× · PMID 29147629 · DOI 10.1080/2162402x.2017.1373237
7. Immune checkpoint inhibitors in the treatment of virus-associated cancers.
   Gao P, Lazare C, Cao C, Meng Y, et al · · 2019 · cited 47× · PMID 31182108 · DOI 10.1186/s13045-019-0743-4
8. Evaluation of PD-L1 Expression and HPV Genotyping in Anal Squamous Cell Carcinoma.
   Wessely A, Heppt MV, Kammerbauer C, Steeb T, et al · · 2020 · cited 26× · PMID 32899762 · DOI 10.3390/cancers12092516