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Clinical Trial 21880

Cancer Type: Gastrointestinal Tumor
Study Type: Treatment
NCT#: NCT04929028

Phase: Phase II
Principal Investigator: Sanchez, Julian

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Study Title

Risk-Adapted Therapy of HIV-Associated Anal Cancer


This phase II trial studies the side effects of chemotherapy and intensity modulated radiation therapy in treating patients with low-risk HIV-associated anal cancer, and nivolumab after standard of care chemotherapy and radiation therapy in treating patients with high-risk HIV-associated anal cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as mitomycin, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with radiation therapy may kill more tumor cells. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving nivolumab after standard of care chemotherapy and radiation therapy may help reduce the risk of the tumor coming back.


1. To determine the safety of reduced intensity CRT in low-risk disease. 2. To determine the safety of nivolumab after standard CRT in high-risk disease.



Chemotherapy (NOS); Immunotherapy; Radiotherapy


5-fluorouracil (); BMS-936558 (Nivolumab); Nivolumab (Opdivo); Radiotherapy (); Xeloda (capecitabine); capecitabine (); mitomycin c ()

Inclusion Criteria

  • Participant is able to understand and willing to sign a written informed consent document
  • Participant must have histologically proven stage (T3-T4N0M0 OR T2-4N1M0) invasive squamous cell carcinoma (SCC) of the anus or anorectum as documented before CRT initiation, according to the American Joint Committee on Cancer (AJCC) 8th edition. Participants with squamous cell carcinoma of the anal margin are eligible if there is evidence of extension of the primary tumor into the anal canal. Participants with tumors of non-keratinizing histology such as basaloid, transitional cell or cloacogenic histology are permitted
  • HIV-positive
  • Age >= 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status == 50%)
  • Life expectancy of greater than 6 months
  • Females of childbearing potential must agree to follow contraception requirements
  • Must have a CD4 count of >= 100 cells/uL at least 2 weeks prior to enrollment OR >= 100 cells/uL before receiving prior CRT, as CD4 may be low due to the effects of CRT
  • Must be on a stable antiretroviral therapy (ART) regimen for at least 2 weeks prior to enrollment with no intention to change the regimen within 12 weeks after enrollment
  • Must have an HIV RNA viral load of > Must have received at least 54 Gy of radiation to the PTVp (primary) and 45 Gy to PTVn (elective nodal region) for the treatment of the anal cancer within 9 weeks before enrollment
  • Must have => Additional Criteria will apply
  • ECOG performance status == 50%)
  • Must agree to follow contraception requirements
  • Must have a CD4 count of >= 100 cells/uL at least 2 weeks before enrollment
  • Must on a stable ART regimen for at least 2 weeks before enrollment and receive appropriate care and treatment for HIV infection under the care of a physician experienced in HIV management
  • Has a HIV RNA viral load of > Has started an alternative anti-coagulant regimen within 2 weeks prior to enrollment if taking warfarin and considering capecitabine
  • Must agree to having phenytoin levels checked weekly if planning to receive capecitabine while taking phenytoin for a seizure disorder
  • Additional Criteria will apply

  • Exclusion Criteria

  • Any live vaccines within 30 days prior to enrollment
  • Has known interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity
  • Prior treatment with an immune checkpoint inhibitor (anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4 monoclonal antibody)
  • Participant with an allogenic bone marrow/stem, cell or solid organ transplant
  • Participant is receiving any other investigational agents
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab or other agents used in study
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with study requirements
  • Participant has a history of a different malignancy, unless he/she have been disease-free for at least 2 years and are deemed by the investigator to be at low risk of recurrence
  • Pregnant or breastfeeding
  • Has not recovered from adverse events due to CRT
  • Has had prior potentially curative surgery
  • Is receiving other standard anti-cancer therapy or experimental agent concurrently with the study drugs
  • Has a known autoimmune disease
  • Participant requires steroid treatment or other immunosuppressive treatment
  • Any surgery must have been completed >= 4 weeks before treatment initiation
  • Has undergone prior potentially curative surgery (i.e., abdominal-perineal resection) for carcinoma of the anus
  • Receiving any other standard anti-cancer therapy or investigational agents concurrently with study therapy
  • Significant cardiovascular disease including myocardial infarction, unstable angina, stroke, transient ischemic attack, symptomatic coronary artery disease, symptomatic congestive heart failure, or uncontrolled cardiac arrhythmia within 6 months of enrollment
  • History of prior chemotherapy for this malignancy
  • Pregnant and/or breast-feeding women

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