5 completed, 5 terminated, 3 active not recruiting, 1 not yet recruiting. 14 Phase 2, 6 Phase 1, 1 Early Phase 1, 1 Phase 3.
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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 |
| 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 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 |
| 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 |
| Intensive Locoregional Chemoimmunotherapy for Recurrent Ovarian Cancer Plus Intranodal DC Vaccines Cisplatin + celecoxib + DC vaccine, Cisplatin + CKM + Celecoxib + DC Vaccine - Cancer of Ovary, Cancer of the Ovary | Phase 1 / Phase 2 | Withdrawn | Roswell Park Cancer Institute | 2015-09-04 | 2026-07-08 | |
| 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 |
| A Randomized, Dose-ranging Study of Alferon LDO in Asymptomatic HIV+ Subjects Alferon LDO - HIV Infections | Phase 2 | Terminated | AIM ImmunoTech Inc. | 17 | 2005-07-01 | 2013-09-04 |
| Study of Alferon® LDO (Low Dose Oral) in Normal Volunteers Alferon LDO - Severe Acute Respiratory Syndrome | Phase 2 | Completed | AIM ImmunoTech Inc. | 10 | 2004-11-01 | 2013-04-17 |
| 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 |
| The Study of the Safety and Efficacy of Ampligen in Chronic Fatigue Syndrome Ampligen - Chronic Fatigue Syndrome, Myalgic Encephalomyelitis | Phase 3 | Completed | AIM ImmunoTech Inc. | 234 | 1998-12-01 | 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 |
HIV Infections (3) · Fatigue Syndrome, Chronic (2) · HIV Seropositivity (2) · Ovarian Neoplasms (2) · Pancreatic Neoplasms (2) · Colorectal Neoplasms (1) · Hematologic Neoplasms (1) · Influenza, Human (1) · Neoplasm Metastasis (1) · Post-Acute COVID-19 Syndrome (1) · Prostatic Neoplasms (1) · Recurrence (1) · Severe Acute Respiratory Syndrome (1) · Triple Negative Breast Neoplasms (1)
poly(I).poly(c12,U) (14) · Interferon alpha-2 (5) · Celecoxib (4) · Introns (4) · Cisplatin (3) · pembrolizumab (3) · Aspirin (1) · Benzenesulfonamides (1) · Biopsy (1) · Creatine Kinase, MM Form (1) · Cytoreduction Surgical Procedures (1) · FluMist (1) · Interferon-alpha (1) · Neurofibromin 2 (1) · Paclitaxel (1)
United States (14) · Hong Kong (1) · Netherlands (1)
David R Strayer, MD (7) · Robert Edwards, MD (2) · Amer H Zureikat, MD (1) · Casper van Eijck, Prof, MD, PhD (1) · Daniel Peterson, M.D. (1) · Gurkamal S Chatta (1) · Igor Puzanov (1) · Marjolein Homs, PhD (1) · Robert P Edwards, MD (1) · Shipra Gandhi, MD (1) · Songul Kucukcelebi, MD (1) · Tommy R. Tong, M.D. (1) · Vincent F. Hillman, M.D. (1)
PMID 22431963, PMID 25128802, PMID 33119613, PMID 35046055
P01CA132714 (1), P30CA016056 (1)