7 completed, 6 terminated, 3 active not recruiting, 1 not yet recruiting. 17 Phase 2, 9 Phase 1, 1 Early Phase 1.
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Ampligen Combined With SOC Versus SOC Alone Following First-Line Therapy in Subjects With LAPC Rintatolimod - Pancreatic Cancer | Phase 2 | Suspended | AIM ImmunoTech Inc. | 90 | 2027-08-01 | 2026-08-19 |
| Intensive Locoregional Chemoimmunotherapy, Intradermal Autologous Alpha-DC1 Vaccines, and Systemic Pembrolizumab for Advanced-Stage Ovarian Cancer Paclitaxel, Cisplatin, Bioferon - Ovarian Cancer | Phase 2 | Not yet recruiting | Kalinski, Pawel, MD, PhD | 28 | 2026-10-01 | 2026-10-13 |
| Polarized Dendritic Cell (aDC1) Based Treatment, Interferon Alpha-2, Rintatolimod, and Celecoxib for the Treatment of HLA-A2+ Refractory Melanoma Alpha-type-1 Polarized Dendritic Cells, Celecoxib, PD-1 Ligand Inhibitor - HLA-A2 Positive Cells Present, Refractory Melanoma | Phase 2 | Terminated | Roswell Park Cancer Institute | 1 | 2024-11-13 | 2026-02-25 |
| Rintatolimod, Celecoxib and Interferon Alpha 2b With Pembrolizumab For the Treatment of Patients With Metastatic or Unresectable Triple Negative Breast Cancer Biopsy, Biospecimen Collection, Celecoxib - Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Triple-Negative Breast Carcinoma | Phase 1 / Phase 2 | Terminated | Roswell Park Cancer Institute | 5 | 2024-02-16 | 2026-08-31 |
| Combining Anti-PD-L1 Immune Checkpoint Inhibitor Durvalumab With TLR-3 Agonist Rintatolimod in Patients With Metastatic Pancreatic Ductal Adenocarcinoma for Therapy Efficacy Durvalumab, Rintatolimod - Metastatic Pancreatic Cancer | Phase 1 / Phase 2 | Active not recruiting | Joachim Aerts, MD PhD | 43 | 2024-01-09 | 2026-09-29 |
| Study to Evaluate the Efficacy and Safety of Ampligen in Patients With Post-COVID Conditions Rintatolimod, Placebo / Normal Saline - Post COVID-19 Condition, Long COVID | Phase 2 | Completed | AIM ImmunoTech Inc. | 80 | 2023-06-30 | 2025-01-22 |
| Rintatolimod and Pembrolizumab for the Treatment of Refractory Metastatic or Unresectable Colorectal Cancer Pembrolizumab, Questionnaire Administration, Rintatolimod - Metastatic Colorectal Adenocarcinoma, Microsatellite Stable | Phase 2 | Withdrawn | Roswell Park Cancer Institute | 2022-02-01 | 2022-02-08 | |
| Rintatolimod and IFN Alpha-2b for the Treatment of COVID-19 in Cancer Patients Recombinant Interferon Alfa-2b, Rintatolimod - Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm | Phase 1 / Phase 2 | Terminated | Roswell Park Cancer Institute | 4 | 2020-11-17 | 2026-01-13 |
| Chemokine Modulation Therapy and Standard Chemotherapy Before Surgery for the Treatment of Early Stage Triple Negative Breast Cancer Celecoxib, Cyclophosphamide, Doxorubicin - Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8 | Phase 1 | Completed | Roswell Park Cancer Institute | 9 | 2019-12-06 | 2023-09-11 |
| Aspirin and Rintatolimod With or Without Interferon-alpha 2b in Treating Patients With Prostate Cancer Before Surgery EC Aspirin, Radical Prostatectomy, Recombinant Interferon Alfa-2b - Prostate Adenocarcinoma, Stage I Prostate Cancer AJCC v8 | Phase 2 | Active not recruiting | Roswell Park Cancer Institute | 12 | 2019-11-29 | 2026-06-09 |
| Systemic Immune Checkpoint Blockade and Intraperitoneal Chemo-Immunotherapy in Recurrent Ovarian Cancer Rintatolimod, Pembrolizumab, Cisplatin - Ovarian Cancer Recurrent | Phase 1 / Phase 2 | Active not recruiting | Robert Edwards | 24 | 2019-01-28 | 2026-02-12 |
| Chemokine Modulation Therapy and Pembrolizumab in Treating Participants With Metastatic Triple-Negative Breast Cancer Biopsy, Chemokine Modulation Therapy, Celecoxib - Triple -Negative Breast Cancer, Estrogen Receptor Negative | Early Phase 1 | Completed | Roswell Park Cancer Institute | 8 | 2019-01-09 | 2023-07-18 |
| Celecoxib, Recombinant Interferon Alfa-2b, and Rintatolimod in Treating Patients With Colorectal Cancer Metastatic to the Liver Celecoxib, Laboratory Biomarker Analysis, Recombinant Interferon Alfa-2b - Metastatic Carcinoma in the Liver, Recurrent Colorectal Carcinoma | Phase 2 | Completed | Roswell Park Cancer Institute | 19 | 2018-04-19 | 2022-03-02 |
| αDC1 Vaccine + Chemokine Modulatory Regimen (CKM) as Adjuvant Treatment of Peritoneal Surface Malignancies DC vaccine, Celecoxib, Interferon Alfa-2b - Malignant Neoplasm of Pancreas Metastatic to Peritoneal Surface, Malignant Peritoneal Mesothelioma | Phase 1 / Phase 2 | Completed | David Bartlett | 64 | 2014-07-01 | 2020-07-20 |
| Chemokine-Modulatory Regimen for Recurrent Resectable Colorectal Cancer Chemokin Modulatory Regimen (5 MU/m2), Chemokin Modulatory Regimen (10 MU/m2), Chemokin Modulatory Regimen (20 MU/m2) - Colorectal Cancer, Colorectal Carcinoma | Phase 1 / Phase 2 | Terminated | Roswell Park Cancer Institute | 15 | 2012-10-01 | 2023-10-27 |
| Safety Study of FluMist With and Without Ampligen Poly I:Poly C12U 50 ug, Poly I:Poly C12U 200 ug, Poly I:Poly C12U 500 ug - Influenza, Human | Phase 1 / Phase 2 | Terminated | AIM ImmunoTech Inc. | 55 | 2012-04-01 | 2018-07-26 |
| Vaccine Therapy in Combination With Rintatolimod and/or Sargramostim in Treating Patients With Stage II-IV HER2-Positive Breast Cancer HER-2/neu peptide vaccine, sargramostim, rintatolimod - HER2-positive Breast Cancer, Male Breast Cancer | Phase 1 / Phase 2 | Completed | University of Washington | 50 | 2011-07-01 | 2020-02-10 |
| The Role of Ampligen in Strategic Therapeutic Intervention (STI) of HAART poly I-poly C12U - HIV Seropositivity, HIV Infection | Phase 2 | Completed | AIM ImmunoTech Inc. | 40 | 2001-05-01 | 2013-04-17 |
| Safety and Efficacy of Ampligen in the Treatment of HIV Patients Failing HAART poly I-poly C12U - HIV Seropositivity, HIV Infection | Phase 2 | Terminated | AIM ImmunoTech Inc. | 16 | 2001-05-01 | 2013-04-17 |
| Ampligen in Chronic Fatigue Syndrome Poly I: Poly C12U (Rintatolimod) - Chronic Fatigue Syndrome | Temporarily not available | AIM ImmunoTech Inc. | 2025-10-29 |
Colorectal Neoplasms (3) · Triple Negative Breast Neoplasms (3) · Breast Neoplasms (2) · HIV Infections (2) · HIV Seropositivity (2) · Pancreatic Neoplasms (2) · Breast Carcinoma In Situ (1) · Breast Neoplasms, Male (1) · Fatigue Syndrome, Chronic (1) · Hematologic Neoplasms (1) · Influenza, Human (1) · Melanoma (1) · Neoplasm Metastasis (1) · Ovarian Neoplasms (1) · Peritoneal Neoplasms (1)
Roswell Park Cancer Institute (9) · AIM ImmunoTech Inc. (6) · David Bartlett (1) · Joachim Aerts, MD PhD (1) · Kalinski, Pawel, MD, PhD (1) · Robert Edwards (1) · University of Washington (1)
United States (19) · Netherlands (1)
David R Strayer, MD (5) · Igor Puzanov (2) · Robert Edwards, MD (2) · Amer H Zureikat, MD (1) · Casper van Eijck, Prof, MD, PhD (1) · Christos Fountzilas, MD (1) · Daniel Peterson, M.D. (1) · David L Bartlett, MD (1) · Ellis Levine, MD (1) · Gurkamal S Chatta (1) · Lupe Salazar (1) · Marjolein Homs, PhD (1) · Sarbajit Mukherjee, MD (1) · Shipra Gandhi (1) · Shipra Gandhi, MD (1)
P01CA234212 (3), P01CA132714 (1), P30CA015704 (1), P30CA016056 (1), UL1TR001412 (1)