Ipilimumab, Nivolumab, and Radiation Therapy in Treating Patients With HPV Positive Advanced Oropharyngeal Squamous Cell Carcinoma
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|ClinicalTrials.gov Identifier: NCT03799445|
Recruitment Status : Not yet recruiting
First Posted : January 10, 2019
Last Update Posted : January 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|CDKN2A-p16 Positive Human Papillomavirus DNA Human Papillomavirus mRNA Human Papillomavirus Positive Oropharyngeal Squamous Cell Carcinoma Oropharyngeal Basaloid Carcinoma Posterior Tongue Squamous Cell Carcinoma Soft Palate Squamous Cell Carcinoma Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7 Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7 Tonsillar Squamous Cell Carcinoma||Radiation: Intensity-Modulated Radiation Therapy Biological: Ipilimumab Biological: Nivolumab Other: Quality-of-Life Assessment Other: Questionnaire Administration||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Study (With Safety Lead in) of the Safety, Tolerability and Efficacy of Anti-CTLA4 (Ipilimumab) and Anti-PD-1 (Nivolumab) in Combination With Radiation Therapy to 60 Gy in Low-Intermediate Volume, Local-Regionally Advanced HPV-Positive Oropharyngeal Squamous Cell Carcinoma (OPSCC)|
|Estimated Study Start Date :||May 7, 2019|
|Estimated Primary Completion Date :||April 28, 2021|
|Estimated Study Completion Date :||April 28, 2021|
Experimental: Treatment (nivolumab, ipilimumab, IMRT)
Patients receive nivolumab IV over 30 minutes on days 1, 15, and 29 and ipilimumab IV over 30 minutes on day 1. Treatment repeats every for 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Beginning on day 1 of course 2, patients also undergo IMRT 5 days a week (Monday-Friday) for 6 weeks in the absence of disease progression or unacceptable toxicity.
Radiation: Intensity-Modulated Radiation Therapy
Other: Quality-of-Life Assessment
Other Name: Quality of Life Assessment
Other: Questionnaire Administration
- Dose limiting toxicity (DLT) (safety lead-in) [ Time Frame: Up to 28 days post-completion of radiation therapy ]Defined as any >= grade 3 adverse event (Common Terminology Criteria for Adverse Events [CTCAE], version [v.] 4) that is related to immunotherapy (IO) that does not resolve to grade 1 or less within 28 days.
- Complete response rate (Phase II) [ Time Frame: At 6 months ]
- Progression-free survival (PFS) (Phase II) [ Time Frame: From start of therapy to progression or disease or death from any cause, assessed up to 2 years ]
- Number of patients who experience a >= grade 3 treatment-related adverse event (safety lead-in) [ Time Frame: Up to 28 days post-completion of radiation therapy ]
- Number of patients who tolerated protocol therapy (safety lead-in) [ Time Frame: Up to 12 weeks (end of course 2) ]The number of patients who tolerated protocol therapy, including completion of radiotherapy without a treatment break and who were administered immunotherapy (IO) will be assessed.
- Number of patients who achieve a clinical complete response (safety lead-in) [ Time Frame: Up to 28 weeks after radiation therapy ]
- Incidence of acute and chronic adverse events (Phase II) [ Time Frame: Up to 3 months from the end of intensity-modulated radiation therapy (IMRT) ]Incidence of adverse events (acute and chronic toxicities) will be assessed per CTCAE Patient Reported Outcome (PRO).
- Acute toxicity profiles (Phase II) assessed by CTCAE v 4. [ Time Frame: From start of treatment up to 6 months ]Will be assessed by CTCAE v 4.
- Number of patients who experience >= grade 3 treatment-related adverse event (Phase II) [ Time Frame: From start of treatment up to 6 months ]
- Toxicity profiles (Phase II) assessed per CTCAE v 4. [ Time Frame: At 1 and 2 years ]Will be assessed per CTCAE v 4.
- Patient-reported swallowing outcomes (Phase II) determined by M. D. Anderson Symptom Inventory - Head & Neck (MDASI-HN) [ Time Frame: At 1 and 2 years ]M. D. Anderson Symptom Inventory - Head & Neck (MDASI-HN) scale ranges from "0 meaning Not Present" to "10 meaning As Bad As You Can Imagine".
- Patterns of failure (local-regional relapse) versus [vs] distant) (Phase II) determined by RECIST 1.1 [ Time Frame: At 1 and 2 years ]
- Overall survival (Phase II) [ Time Frame: At 1 and 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03799445
|Contact: Maura Gillisonfirstname.lastname@example.org|
|United States, Texas|
|M D Anderson Cancer Center||Not yet recruiting|
|Houston, Texas, United States, 77030|
|Contact: Maura L. Gillison 713-792-6363|
|Principal Investigator: Maura L. Gillison|
|Principal Investigator:||Maura Gillison||M.D. Anderson Cancer Center|