Table 2.
Active clinical trials combining radiation with PD-1/PD-L1 targeted therapy
| NCT Number | Phase | Title | Conditions | RT Details | Enrollment | Sponsor/Collaborators |
|---|---|---|---|---|---|---|
| NCT02642809 | Phase 0 | Pembrolizumab With Locally Delivered Radiation Therapy for the Initial Treatment of Metastatic Esophageal Cancers | Esophageal Cancer | Hypofx brachytherapy | 15 | Washington University School of Medicine|Merck Sharp & Dohme Corp. |
| NCT02463994 | Phase 0 | A Pilot Study of MPDL3280A and HIGRT in Metastatic NSCLC | NSCLC | Hypofx RT | 12 | University of Michigan Cancer Center|University of Washington |
| NCT02587455 | Phase 1 | Pembrolizumab and Palliative Radiotherapy in Lung | Thoracic Tumours | Palliative EBRT | 48 | Royal Marsden NHS Foundation Trust|Merck Sharp & Dohme Corp. |
| NCT02608385 | Phase 1 | Study of PD1 Blockade by Pembrolizumab With Stereotactic Body Radiotherapy in Advanced Solid Tumors | NSCLC | SBRT, 3-5 fx | 138 | University of Chicago |
| NCT02621398 | Phase 1 | Pembrolizumab, Paclitaxel, Carboplatin, and Radiation Therapy in Treating Patients With Stage II-IIIB NSCLC | NSCLC | EBRT | 30 | Rutgers, The State University of New Jersey|National Cancer Institute (NCI)|Merck Sharp & Dohme Corp. |
| NCT02313272 | Phase 1 | Phase I Trial of Hypofractionated Stereotactic Irradiation (HFSRT) With Pembrolizumab and Bevacizumab for Recurrent High Grade Gliomas | Malignant Glioma | FSRT over 5 days | 32 | H. Lee Moffitt Cancer Center and Research Institute|Merck Sharp & Dohme Corp. |
| NCT02402920 | Phase 1 | Phase I Trial of MK-3475 and Concurrent Chemo/Radiation for the Elimination of Small Cell Lung Cancer | Lung Cancer | EBRT, 1.5 Gy × 30 fx, BID | 80 | M.D. Anderson Cancer Center|Merck Sharp & Dohme Corp. |
| NCT02716948 | Phase 1 | Stereotactic Radiosurgery and Nivolumab in Treating Patients With Newly Diagnosed Melanoma Metastases in the Brain or Spine | Melanoma (Brain metastases) | SRS | 90 | Sidney Kimmel Comprehensive Cancer Center |
| NCT02560636 | Phase 1 | Pembrolizumab in Muscle Invasive/Metastatic Bladder Cancer | Invasive Bladder Cancer | Hypofx RT | 34 | Royal Marsden NHS Foundation Trust|Merck Sharp & Dohme Corp. |
| NCT02318771 | Phase 1 | Radiation Therapy and MK-3475 for Patients With Recurrent/Metastatic Head and Neck Cancer, Renal Cell Cancer, Melanoma, and Lung Cancer | Metastatic HN, RCC, Melanoma, Lung Cancer | EBRT | 40 | Thomas Jefferson University|Merck Sharp & Dohme Corp. |
| NCT02648633 | Phase 1 | Stereotactic Radiosurgery With Nivolumab and Valproate in Patients With Recurrent Glioblastoma | Glioblastoma | SRS | 17 | University of Virginia |
| NCT02303366 | Phase 1 | Pilot Study of Stereotactic Ablation for Oligometastatic Breast Neoplasia in Combination With the Anti-PD-1 Antibody MK-3475 | Oligometastatic Breast Cancer | SBRT, 20 Gy × 1 fx | 15 | Peter MacCallum Cancer Centre, Australia |
| NCT02659540 | Phase 1 | A Pilot Study to Evaluate the Safety and Efficacy of Combination Checkpoint Blockade Plus External Beam Radiotherapy in Subjects With Stage IV Melanoma | Melanoma | 3 Gy × 10 fx, or 9 Gy × 3 fx | 18 | Ludwig Institute for Cancer Research|Bristol-Myers Squibb |
| NCT02586207 | Phase 1 | Pembrolizumab in Combination With CRT for LA-SCCHN | Advanced HN Cancers | EBRT, 7 wks | 39 | Sanford Health|Merck Sharp & Dohme Corp. |
| NCT02303990 | Phase 1 | RADVAX: A Stratified Phase I Trial of Pembrolizumab With Hypofractionated Radiotherapy in Patients With Advanced and Metastatic Cancers | Metastatic Cancers | Hypofx RT | 70 | Abramson Cancer Center of the University of Pennsylvania |
| NCT02764593 | Phase 1 | Chemotherapy +/- Nivolumab in Patients With Intermediate and High-Risk Local-Regionally Advanced Head and Neck Squamous Cell Carcinoma | Advanced HN Cancers | IMRT, 7 wks | 120 | RTOG Foundation, Inc.|Bristol-Myers Squibb |
| NCT02400814 | Phase 1 | MPDL3280A and Stereotactic Ablative Radiotherapy in Patients With NSCLC | NSCLC | SBRT, 5 fx | 45 | University of California, Davis|National Cancer Institute (NCI)|Genentech, Inc. |
| NCT02383212 | Phase 1 | Study of REGN2810 (Anti-PD-1) in Patients With Advanced Malignancies | Advanced Cancer | Hypofx RT | 973 | Regeneron Pharmaceuticals|Sanofi |
| NCT02311361 | Phase 1 | Immune Checkpoint Inhibition (Tremelimumab and/or MEDI4736) in Combination With Radiation Therapy in Patients With Unresectable Pancreatic Cancer | Pancreatic Cancer | SBRT, 1-5 fx | 60 | National Cancer Institute (NCI)|National Institutes of Health Clinical Center (CC) |
| NCT02696993 | Phase 1|Phase 2 | Phase I/II Trial of Nivolumab With Radiation or Nivolumab and Ipilimumab With Radiation for the Treatment of Intracranial Metastases From NSCLC | Lung Cancer (Brain metastases) | WBRT 3 Gy × 10 fx, SRS 1 fx | 80 | M.D. Anderson Cancer Center|Bristol-Myers Squibb |
| NCT02444741 | Phase 1|Phase 2 | MK-3475 and Hypofractionated Stereotactic Radiation Therapy in Patients With NSCLC (NSCLC) | Lung Cancer | EBRT or SBRT | 104 | M.D. Anderson Cancer Center|Merck Sharp & Dohme Corp. |
| NCT02530502 | Phase 1|Phase 2 | Radiation Therapy With Temozolomide and Pembrolizumab in Treating Patients With Newly Diagnosed Glioblastoma | Glioblastoma | EBRT | 50 | Northwestern University|Merck Sharp & Dohme Corp.|National Cancer Institute (NCI) |
| NCT02730546 | Phase 1|Phase 2 | Pembrolizumab, Combination Chemotherapy, and Radiation Therapy Before Surgery in Treating Adult Patients With Locally Advanced Gastroesophageal Junction or Gastric Cardia Cancer That Can Be Removed by Surgery | Gastric Cancer | EBRT | 68 | Mayo Clinic|National Cancer Institute (NCI) |
| NCT02759575 | Phase 1|Phase 2 | A Study of Chemoradiation Plus Pembrolizumab for Locally Advanced Laryngeal Squamous Cell Carcinoma | Advanced HN Cancers | EBRT | 47 | Nooshin Hashemi-Sadraei|Merck Sharp & Dohme Corp.|University of Cincinnati |
| NCT02407171 | Phase 1|Phase 2 | Evaluating the Combination of MK-3475 and Sterotactic Body Radiotherapy in Patients With Metastatic Melanoma or NSCLC | Melanoma, Lung Cancer | SBRT, 1-5 fx | 60 | Yale University |
| NCT02735239 | Phase 1|Phase 2 | Study of Anti-PD-L1 in Combination With Chemo(Radio)Therapy for Oesophageal Cancer | Esophageal Cancer | EBRT | 75 | Ludwig Institute for Cancer Research|AstraZeneca |
| NCT02305186 | Phase 1|Phase 2 | Safety and Immunological Effect of Pembrolizumab in Resectable or Borderline Resectable Pancreatic Cancer | Pancreatic Cancer | EBRT, 1.8 Gy × 28 fx | 56 | Osama Rahma, MD|M.D. Anderson Cancer Center|University of Virginia |
| NCT02599779 | Phase 2 | A Proof of Principle Study of Pembrolizumab With SBRT in TKI mRCC Patients | Metastatic RCC | SBRT | 35 | Sunnybrook Health Sciences Centre|Merck Sharp & Dohme Corp.|Ozmosis Research Inc. |
| NCT02648282 | Phase 2 | Study With CY, Pembrolizumab, GVAX, and SBRT in Patients With Locally Advanced Pancreatic Cancer | Pancreatic Cancer | SBRT, 3-5 fx | 54 | Sidney Kimmel Comprehensive Cancer Center|Merck Sharp & Dohme Corp. |
| NCT02492568 | Phase 2 | Pembrolizumab After SBRT Versus Pembrolizumab Alone in Advanced NSCLC | NSCLC | SBRT, 8 Gy × 3 fx | 74 | The Netherlands Cancer Institute|Merck Sharp & Dohme Corp. |
| NCT02641093 | Phase 2 | Phase II Trial of Adjuvant Cisplatin and Radiation With Pembrolizumab in Resected Head and Neck Squamous Cell Carcinoma | HN Cancer | EBRT, 6 wks | 80 | Trisha Wise-Draper|Merck Sharp & Dohme Corp.|University of Cincinnati |
| NCT02684253 | Phase 2 | Screening Trial of Nivolumab With Image Guided, Stereotactic Body Radiotherapy (SBRT) Versus Nivolumab Alone in Patients With Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) | HN Cancer | SBRT, 9 Gy x 3 fx | 40 | Memorial Sloan Kettering Cancer Center|University of Chicago |
| NCT02667587 | Phase 2 | Study of Temozolomide Plus Radiation Therapy With Nivolumab or Placebo, for Newly Diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer). | Glioblastoma | EBRT | 320 | Bristol-Myers Squibb|Ono Pharmaceutical Co. Ltd |
| NCT02437071 | Phase 2 | Assess the Efficacy of Pembrolizumab Plus Radiotherapy or Ablation in Metastatic Colorectal Cancer Patients | Metastatic Colorectal Cancer | EBRT vs radiofrequency ablation | 48 | Memorial Sloan Kettering Cancer Center|Merck Sharp & Dohme Corp. |
| NCT02658097 | Phase 2 | A Randomized Two Arm Phase II Trial of Pembrolizumab Alone or Sequentially Following Single Fraction Non-ablative Radiation to One of the Target Lesions, in Previously Treated Patients With Stage IV NSCLC | Stage IV NSCLC | 8 Gy × 1 fx | 66 | Case Comprehensive Cancer Center |
| NCT02562625 | Phase 2 | Trial of Pembrolizumab and Radiotherapy in Melanoma | Melanoma | 8 Gy × 3 fx | 234 | Royal Marsden NHS Foundation Trust|University of Manchester|University of Leeds |
| NCT02730130 | Phase 2 | Study to Assess the Efficacy of Pembrolizumab Plus Radiotherapy in Metastatic Triple Negative Breast Cancer Patients | Metastatic Breast Cancer | EBRT | 17 | Memorial Sloan Kettering Cancer Center|Merck Sharp & Dohme Corp. |
| NCT02707588 | Phase 2 | Tolerance and Efficacy of Pembrolizumab or Cetuximab Combined With RT in Patients With Locally Advanced HNSCC | Advanced HN Cancers | EBRT | 114 | Groupe Oncologie Radiotherapie Tete et Cou |
| NCT02621151 | Phase 2 | Pembrolizumab (MK3475), Gemcitabine, and Concurrent Hypofractionated Radiation Therapy for Muscle-Invasive Urothelial Cancer of the Bladder | Muscle-invasive Urothelial Cancer of the Bladder | Hypofx RT | 54 | New York University School of Medicine|Merck Sharp & Dohme Corp. |
| NCT02609503 | Phase 2 | Pembrolizumab + Radiation for Locally Adv SCC of the Head and Neck (SCCHN) Not Eligible Cisplatin | Head and Neck Cancer | IMRT, 7 wks | 29 | UNC Lineberger Comprehensive Cancer Center|Merck Sharp & Dohme Corp. |
| NCT02677155 | Phase 2 | Sequential Intranodal Immunotherapy (SIIT) Combined With Anti-PD1 (Pembrolizumab) in Follicular Lymphoma | Follicular Lymphoma | 8 Gy × 1 fx | 20 | Oslo University Hospital|Norwegian Cancer Society|Merck Sharp & Dohme Corp. |
| NCT02586610 | Phase 2 | Trial of Chemoradiation and Pembrolizumab in Patients With Rectal Cancer | Rectal Cancer | EBRT, 1.8 Gy × 28 fx | 53 | Osama Rahma, MD|Hoosier Cancer Research Network|Merck Sharp & Dohme Corp. |
| NCT02434081 | Phase 2 | NIvolumab COnsolidation After Standard First-line Chemotherapy and Radiotherapy in Locally Advanced Stage IIIA/B NSCLC | NSCLC | EBRT | 43 | European Thoracic Oncology Platform|Bristol-Myers Squibb|Frontier Science Foundation, Hellas |
| NCT02296684 | Phase 2 | Immunotherapy With MK-3475 in Surgically Resectable Head and Neck Squamous Cell Carcinoma | HN Cancer | IMRT, 6 wks | 46 | Washington University School of Medicine|Merck Sharp & Dohme Corp. |
| NCT02499367 | Phase 2 | Nivolumab After Induction Treatment in Triple-negative Breast Cancer (TNBC) Patients | Breast Cancer | 20 Gy × 1, or 8 Gy × 3 | 84 | The Netherlands Cancer Institute|Bristol-Myers Squibb |
| NCT02635360 | Phase 2 | Pembrolizumab and Chemoradiation Treatment for Advanced Cervical Cancer | Cervical Cancer | EBRT + brachytherapy | 88 | Linda R Duska|Merck Sharp & Dohme Corp.|University of Virginia |
| NCT02662062 | Phase 2 | Pembrolizumab With Chemoradiotherapy as Treatment for Muscle Invasive Bladder Cancer | Bladder Cancer | EBRT, 6 wks | 30 | Australian and New Zealand Urogenital and Prostate Cancer Trials Group |
| NCT02336165 | Phase 2 | Phase 2 Study of MEDI4736 in Patients With Glioblastoma | Glioblastoma | EBRT | 108 | Ludwig Institute for Cancer Research|MedImmune LLC |
| NCT02289209 | Phase 2 | Reirradiation With MK-3475 (Pembrolizumab) in Locoregional Inoperable Recurrence or Second Primary Squamous Cell CA of the Head and Neck | Recurrent HN Cancers | EBRT | 48 | Dan Zandberg|Merck Sharp & Dohme Corp.|University of Maryland |
| NCT02768558 | Phase 3 | Cisplatin and Etoposide Plus Radiation Followed By Nivolumab/Placebo For Locally Advanced NSCLC | NSCLC | EBRT (IMRT or 3D CRT) | 660 | RTOG Foundation, Inc.|Bristol-Myers Squibb |
| NCT02617589 | Phase 3 | Study of Nivolumab Versus Temozolomide, Given With Radiation Therapy, for Newly-diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer) | Brain Cancer | EBRT | 550 | Bristol-Myers Squibb|Ono Pharmaceutical Co. Ltd |
Abbreviations: 3D CRT 3-dimensional conformal radiation therapy, EBRT external beam radiation in conventional fractions, fx fractions, hypofx hypofractionated, IMRT intensity modulated radiation therapy, FSRT fractionated stereotactic radiation, HN head and neck, SBRT stereotactic body radiation therapy, SRS stereotactic radiosurgery