Rintatolimod

DRUG14 trials

Sponsors

University of Washington, David Bartlett, Roswell Park Cancer Institute, Robert Edwards, AIM ImmunoTech Inc.

Conditions

Anatomic Stage 0 Breast Cancer AJCC v8Anatomic Stage I Breast Cancer AJCC v8Anatomic Stage IA Breast Cancer AJCC v8Anatomic Stage IB Breast Cancer AJCC v8Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage IIA Breast Cancer AJCC v8Anatomic Stage IIB Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC

Early Phase 1

Chemokine Modulation Therapy and Pembrolizumab in Treating Participants With Metastatic Triple-Negative Breast Cancer

CompletedNCT03599453

Roswell Park Cancer InstituteAnatomic Stage IV Breast Cancer AJCC, Estrogen Receptor Negative, HER2/Neu Negative +2

Start: 2019-01-09End: 2023-03-21Updated: 2023-07-18

Phase 1

Vaccine Therapy in Combination With Rintatolimod and/or Sargramostim in Treating Patients With Stage II-IV HER2-Positive Breast Cancer

CompletedNCT01355393

University of WashingtonHER2-positive Breast Cancer, Male Breast Cancer, Recurrent Breast Cancer +5

Start: 2011-07-31Updated: 2020-02-10

αDC1 Vaccine + Chemokine Modulatory Regimen (CKM) as Adjuvant Treatment of Peritoneal Surface Malignancies

CompletedNCT02151448

David BartlettMalignant Neoplasm of Pancreas Metastatic to Peritoneal Surface, Malignant Peritoneal Mesothelioma, Peritoneal Carcinomatosis

Start: 2014-07-31End: 2019-02-18Updated: 2020-07-20

Systemic Immune Checkpoint Blockade and Intraperitoneal Chemo-Immunotherapy in Recurrent Ovarian Cancer

Active, not recruitingNCT03734692

Robert EdwardsOvarian Cancer Recurrent

Start: 2019-01-28End: 2027-01-10Updated: 2026-02-12

Chemokine Modulation Therapy and Standard Chemotherapy Before Surgery for the Treatment of Early Stage Triple Negative Breast Cancer

CompletedNCT04081389

Roswell Park Cancer InstituteAnatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8 +16

Start: 2019-12-06End: 2023-02-27Updated: 2023-09-11

Rintatolimod and IFN Alpha-2b for the Treatment of COVID-19 in Cancer Patients

TerminatedNCT04379518

Roswell Park Cancer InstituteHematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Symptomatic COVID-19 Infection Laboratory-Confirmed

Start: 2020-11-17End: 2023-03-15Updated: 2026-01-13

Rintatolimod, Celecoxib and Interferon Alpha 2b With Pembrolizumab For the Treatment of Patients With Metastatic or Unresectable Triple Negative Breast Cancer

TerminatedNCT05756166

Roswell Park Cancer InstituteAnatomic Stage IV Breast Cancer AJCC v8, Metastatic Triple-Negative Breast Carcinoma, Unresectable Triple-Negative Breast Carcinoma

Start: 2024-02-16End: 2025-06-19Updated: 2025-06-24

Combining Anti-PD-L1 Immune Checkpoint Inhibitor Durvalumab With TLR-3 Agonist Rintatolimod in Patients With Metastatic Pancreatic Ductal Adenocarcinoma for Therapy Efficacy

RecruitingNCT05927142

Joachim Aerts, MD PhDMetastatic Pancreatic Cancer

Start: 2024-01-09End: 2027-04-30Target: 43Updated: 2025-02-25

Phase 2

Celecoxib, Recombinant Interferon Alfa-2b, and Rintatolimod in Treating Patients With Colorectal Cancer Metastatic to the Liver

CompletedNCT03403634

Roswell Park Cancer InstituteMetastatic Carcinoma in the Liver, Recurrent Colorectal Carcinoma, Stage IVA Colorectal Cancer AJCC v7 +2

Start: 2018-04-19End: 2021-08-29Updated: 2022-03-02

Aspirin and Rintatolimod With or Without Interferon-alpha 2b in Treating Patients With Prostate Cancer Before Surgery

Active, not recruitingNCT03899987

Roswell Park Cancer InstituteProstate Adenocarcinoma, Stage IIA Prostate Cancer AJCC v8, Stage IIB Prostate Cancer AJCC v8 +7

Start: 2019-11-29End: 2026-11-29Updated: 2025-08-27

Polarized Dendritic Cell (aDC1) Based Treatment, Interferon Alpha-2, Rintatolimod, and Celecoxib for the Treatment of HLA-A2+ Refractory Melanoma

TerminatedNCT04093323

Roswell Park Cancer InstituteHLA-A2 Positive Cells Present, Refractory Melanoma

Start: 2024-11-13End: 2025-06-19Updated: 2026-02-25

Rintatolimod and Pembrolizumab for the Treatment of Refractory Metastatic or Unresectable Colorectal Cancer

WithdrawnNCT04119830

Roswell Park Cancer InstituteMetastatic Colorectal Adenocarcinoma, Microsatellite Stable, Mismatch Repair Proficient +10

Start: 2022-02-01End: 2024-02-01Updated: 2022-02-08

Ampligen Combined With SOC Versus SOC Alone Following First-Line Therapy in Subjects With LAPC

SuspendedNCT05494697

AIM ImmunoTech Inc.Pancreatic Cancer

Start: 2026-06-30End: 2030-01-31Target: 90Updated: 2025-10-14

Study to Evaluate the Efficacy and Safety of Ampligen in Patients With Post-COVID Conditions

CompletedNCT05592418

AIM ImmunoTech Inc.Long COVID, Post COVID-19 Condition

Start: 2023-06-30End: 2023-11-30Updated: 2025-01-22

Related Papers

Systemic Infusion of dsRNA (Rintatolimod) plus IFNa Selectively Enhances Intratumoral CTL Influx in Cancer Patients 2701

The Journal of Immunology2025-11-01

Systemic chemokine-modulatory regimen combined with neoadjuvant chemotherapy in patients with triple-negative breast cancer

Journal for ImmunoTherapy of Cancer2024-11-014 citations

Phase 2 randomized study of rintatolimod following FOLFIRINOX in patients with locally advanced pancreatic adenocarcinoma.

Journal of Clinical Oncology2024-06-012 citations

Abstract PO1-18-03: Chemokine-modulating regimen (rintatolimod, IFN-α2b, celecoxib): New strategy to drive CD8+T-cells into triple negative breast cancer

Cancer Research2024-05-021 citations

A randomized phase II trial of neoadjuvant chemokine modulation in patients with localized prostate cancer undergoing radical prostatectomy.

Journal of Clinical Oncology2024-01-29

799 Combination intraperitoneal chemoimmunotherapy triggers a T-cell chemotactic locoregional response in patients with recurrent platinum-sensitive ovarian cancer

Regular and Young Investigator Award Abstracts2023-10-31

801 Risk-benefit ratio in immunotherapy (IO) with or without chemotherapy (CT) according to PD-L1 expression: a model-based approach to inform treatment decisions in metastatic non-small cell lung cancer

Regular and Young Investigator Award Abstracts2023-10-31

Abstract P4-06-07: Preliminary indications of safety and efficacy of neoadjuvant chemotherapy plus chemokine-modulating regimen (rintatolimod, IFN-α2b, celecoxib) in triple negative breast cancer

Cancer Research2023-03-01

A randomized phase II trial of neoadjuvant chemokine modulation in patients with localized prostate cancer undergoing radical prostatectomy.

Journal of Clinical Oncology2023-02-20

547 Safety and efficacy of de-escalated neoadjuvant chemoimmunotherapy of triple negative breast cancer (TNBC) using chemokine-modulating regimen (rintatolimod, IFN-α2b, celecoxib)

Regular and Young Investigator Award Abstracts2022-11-013 citations

Abstract CT145: Systemic rintatolimod and interferon-α2b selectively reprogram local tumor microenvironment in patients with metastatic triple negative breast cancer for enhanced influx of cytotoxic T-lymphocytes but not regulatory T-cells

Cancer Research2022-06-153 citations

Abstract CT105: Initial results of a phase II study evaluating a chemokine-modulatory (CKM) regimen in patients with colorectal cancer metastatic to the liver

Cancer Research2022-06-152 citations

Abstract 6134: Combined loco-regional and systemic, triple agent chemoimmunotherapy increases biomarkers of T cell chemotaxis in ovarian cancer

Cancer Research2022-06-151 citations

Dendritic cell vaccines targeting tumor blood vessel antigens in combination with dasatinib induce therapeutic immune responses in patients with checkpoint-refractory advanced melanoma

Journal for ImmunoTherapy of Cancer2021-11-0150 citations

334 Phase II study evaluating a chemokine-modulatory (CKM) regimen in patients with colorectal cancer (CRC) metastatic to the liver

Regular and Young Investigator Award Abstracts2020-11-011 citations

321 Phase I clinical trial assessing the combination of systemic chemokine modulatory regimen targeting TLR3 with neoadjuvant chemotherapy in triple negative breast cancer

Regular and Young Investigator Award Abstracts2020-11-01