Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02296684 | Immunotherapy With MK-3475 in Surgically Resectable Head and Neck Squamous Cell Carcinoma | PHASE2 | COMPLETED | 67 | — | — | Mar 25, 2015 | Jul 21, 2025 | May 8, 2026 | 3 | United States |
-The percentage of participants who developed local-regional recurrence within one year of surgery
-The percentage of participants who developed distant failure within one year of surgery. Distant disease is cancer that is found in another part of the body that is far away from where the original (primary) tumor first formed.
* Major pathologic treatment effect=pathologic tumor response (pTR). * pTR was defined as the presence of tumor cell necrosis and keratinous debris with giant cell/histiocytic reaction, quantified as a percentage of the overall tumor bed (area pathologic response/area pathologic response plus viable tumor): pTR-0 (\>10%), pTR-1 (10-49%), and pTR-2 (≥50%).
* Major pathologic treatment effect=pathologic tumor response (pTR). * pTR was defined as the presence of tumor cell necrosis and keratinous debris with giant cell/histiocytic reaction, quantified as a percentage of the overall tumor bed (area pathologic response/area pathologic response plus viable tumor): pTR-0 (\>10%), pTR-1 (10-49%), and pTR-2 (≥50%).
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-3475 | EXPERIMENTAL | * MK-3475 will be given intravenously once approximately 2-3 weeks prior to standard of care surgery. * Adjuvant therapy will be dictated by surgical pathology and occurs after standard of care surgery and will consist of: * risk-based intensity modulated radiation therapy consisting of 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)once-daily fraction size (total of 30 fractions) * optional image-guided radiation therapy * risk-based cisplatin administered intravenously on Days 1, 22, and 43 of treatment course * MK-3475 will be given intravenously once every 3 weeks for a maximum of 6 doses if participant is considered high-risk based surgical pathology from standard of care surgery. These doses of MK-3475 will be given after surgery and after all acute toxicities of post-operative standard of care chemotherapy and radiation have resolved to grade 1 or less. |
| Cohort 2: Neoadjuvant MK-3475 | EXPERIMENTAL | -MK-3475 will be given once intravenously and then given again 21 days after dose 1 (14-24 days before standard of care surgery) |
| Name | Type | Description |
|---|---|---|
| MK-3475 (neoadjuvant) | BIOLOGICAL | - |
| Surgery | PROCEDURE | Standard of care |
| Intensity modulated radiation therapy | RADIATION | Recommended, standard of care |
| Image-guided radiation therapy | RADIATION | Recommended, standard of care |
| Cisplatin | DRUG | Standard of care |
| MK-3475 (adjuvant) | BIOLOGICAL | - |
| Peripheral blood | PROCEDURE | -Baseline, time of surgery (between day 14-24 inclusive), 3 months post surgery, 6 months post surgery, 9 months post surgery, 12 months post surgery |
Inclusion Criteria: * Histologically or cytologically confirmed stage III or IV HNSCC oral cavity, hypopharynx, oropharynx, larynx (excluding p16 or HPV-positive oropharynx primaries and sinonasal primaries). * Measurable disease defined as lesions that can be accurately measured in at least one di...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 1 | PHASE1 | TG4001, Avelumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Oncolytics Biotech Inc. | ONCY | 1 | PHASE1 | Pelareorep, Atezolizumab, Gemcitabine and nab-paclitaxel, Trifluridine Tipiracil, mFOLFIRINOX Treatment Regimen |
| TScan Therapeutics, Inc. | TCRX | 1 | PHASE1 | TSC-204-A0201, TSC-204-C0702, TSC-200-A0201, TSC-203-A0201, TSC-204-A0101 |