Page 11 - Delaware Medical Journal - July/August 2019

ECOG EA2165: A Randomized Phase II Study of Nivolumab After Combined Modality Therapy (CMT) in High-Risk Anal Cancer
The objectives of the trial are:
Primary Objective:
To evaluate whether therapy with nivolumab following combined modality therapy (CMT) improves Disease-Free Survival (DFS) compared with observation in patients with high-risk anal carcinoma.
Secondary Objective:
• Objective response rate (complete CR and partial PR), stable disease and progression • Severe toxicity interval
• Colostomy-free survival
• Overall survival
• Toxicity
Eligibility:
Registration: Step 1
• Patients must have histologically proven stage IIB (T3N0M0 only), IIIA (T2N1M0), IIIB (T4N0M0), or IIIC (T3N1M0, T4N1M0) invasive squamous cell carcinoma of the anus or anorectum, according to the AJCC 8th edition. This may include tumors of non-keratinizing histology such as basoloid, transitional cell, or cloacogenic histology. Individuals with squamous cell carcinoma of the anal margin are eligible if there is evidence of extension of the primary tumor into the anal canal.
• Adequate hematologic and hepatic functions within 2 weeks prior to registration.
• Age ≥ 18 years. ECOG performance status of 0-2.
• For patients registering prior to start of chemoradiotherapy, baseline scans must have been completed within 4 weeks prior to registration.
• Women of child-bearing potential and males must use an accepted and effective method of contraception. Women must not be pregnant or breast- feeding.
Randomization: Step 2
• Adequate hematologic and hepatic functions within 2 weeks prior to registration.
• Patients 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.
• Scans done within 4 weeks of randomization to Step 2.
• Patient must be able to have recovered from all toxicities associated with chemoradiotherapy for anal cancer, to Grade ≤ 1 with the exception of alopecia.
• Women of child-bearing potential and males must use an accepted and effective method of contraception. Women must not be pregnant or breast- feeding.
Treatment:
Registration: Step 1
Arm T: 5FU/Mitomycin/XRT OR Capecitabine/Mitomycin/XRT OR 5FU/Cisplatin/XRT
OR
Arm S: Standard Chemo/XRT completed
Randomization: Step 2
Arm A: Nivolumab: Cycle 1: 240mg q two weeks THEN 480mg q cycle for a total of 6 cycles OR
Arm B: Observation
For information regarding this clinical trial or if you would like to have the list of open protocols emailed to you, please call the Cancer Research Office at (302) 623-4450 or email akee@christianacare.org.
CANCER CLINICAL TRIAL
Del Med J | July/August 2019 | Vol. 91 | No. 4 155