- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), vidutolimod (CMP-001) / Regeneron
Trial primary completion date: CMP-001 for Relapsed and Refractory Lymphoma (clinicaltrials.gov) - Nov 21, 2024 P1/2, N=39, Active, not recruiting, Trial primary completion date: Apr 2025 --> Aug 2024
- |||||||||| vidutolimod (CMP-001) / Regeneron
Journal, Combination therapy, PD(L)-1 Biomarker, IO biomarker, Metastases: Intratumoral vidutolimod in combination with PD-1 blockade in locoregionally advanced melanoma. (Pubmed Central) - Nov 13, 2024 In this issue of Cancer Cell, Davar and colleagues report a promising phase 2 neoadjuvant trial of the TLR9 agonist vidutolimod in combination with nivolumab. Analyses suggest a unique myeloid expression signature is associated with response.
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), vidutolimod (CMP-001) / Regeneron
Enrollment closed: CMP-001 for Relapsed and Refractory Lymphoma (clinicaltrials.gov) - Nov 12, 2024 P1/2, N=39, Active, not recruiting, Analyses suggest a unique myeloid expression signature is associated with response. Suspended --> Active, not recruiting
- |||||||||| Opdivo (nivolumab) / BMS, vidutolimod (CMP-001) / Regeneron
Biomarker, Trial completion, Trial completion date, Trial primary completion date: Study of TLR9 Agonist Vidutolimod (CMP-001) in Combination with Nivolumab Vs. Nivolumab (clinicaltrials.gov) - Oct 21, 2024 P2, N=9, Completed, Completed --> Terminated; Business Decision Active, not recruiting --> Completed | Trial completion date: Jul 2028 --> Aug 2024 | Trial primary completion date: Jul 2028 --> Aug 2024
- |||||||||| vidutolimod (CMP-001) / Regeneron
Intratumoral injection of vidutolimod, an immunostimulatory virus-like particle, enhances the number of intratumoral and circulating tumor-specific CD8 T cells (Exhibit Halls AB - George R. Brown Convention Center) - Oct 4, 2024 - Abstract #SITC2024SITC_917; Conclusions Vidutolimod induced a greater influx of OT-1 T cells into the primary tumor and in circulation which supports previous studies that saw an abscopal effect of non-treated tumors. Vidutolimod also increased the number of circulation PD-1+ OT-1 T cells which supports clinical research of anti-PD-1 therapy in combination with vidutolimod Ethics Approval Mouse studies were approved by and performed according to guidelines established by the University of Iowa Institutional Animal Care and Use Committee under an approved IACUC Protocol #3011236.
- |||||||||| vidutolimod (CMP-001) / Regeneron
Trial completion, Monotherapy: CMP-001-011: CMP-001 in Combination With Nivolumab Compared to Nivolumab Monotherapy in Subjects With Advanced Melanoma (clinicaltrials.gov) - Aug 14, 2024 P2/3, N=20, Completed, Vidutolimod also increased the number of circulation PD-1+ OT-1 T cells which supports clinical research of anti-PD-1 therapy in combination with vidutolimod Ethics Approval Mouse studies were approved by and performed according to guidelines established by the University of Iowa Institutional Animal Care and Use Committee under an approved IACUC Protocol #3011236. Active, not recruiting --> Completed
- |||||||||| Libtayo (cemiplimab-rwlc) / Regeneron, vidutolimod (CMP-001) / Regeneron
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date, Combination therapy, Metastases: A Trial To Find Out If Vidutolimod Together With Cemiplimab Is Safe And If It Works In Adult Participants With Advanced Cancer Or Metastatic Cancer (clinicaltrials.gov) - Aug 13, 2024 P2, N=77, Active, not recruiting, Active, not recruiting --> Completed Suspended --> Active, not recruiting | N=225 --> 77 | Trial completion date: Jul 2027 --> Oct 2024 | Trial primary completion date: Jul 2027 --> Oct 2024
- |||||||||| Opdivo (nivolumab) / BMS, vidutolimod (CMP-001) / Regeneron
Biomarker, Enrollment closed, Enrollment change, Trial completion date: Study of TLR9 Agonist Vidutolimod (CMP-001) in Combination with Nivolumab Vs. Nivolumab (clinicaltrials.gov) - May 3, 2024 P2, N=9, Active, not recruiting, Phase classification: P1b/2 --> P1/2 Suspended --> Active, not recruiting | N=36 --> 9 | Trial completion date: Jul 2030 --> Jul 2028
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), vidutolimod (CMP-001) / Regeneron
Trial suspension: CMP-001 for Relapsed and Refractory Lymphoma (clinicaltrials.gov) - Mar 26, 2024 P1/2, N=39, Suspended, Recruiting --> Active, not recruiting | N=262 --> 61 | Trial completion date: May 2025 --> Sep 2026 | Trial primary completion date: May 2025 --> Sep 2026 Recruiting --> Suspended
- |||||||||| vidutolimod (CMP-001) / Regeneron
Trial completion date, Trial primary completion date: CMP-001 in Combination With Nivolumab in Subjects With Advanced Melanoma (clinicaltrials.gov) - Feb 15, 2024 P2, N=44, Active, not recruiting, Trial completion date: Mar 2027 --> Jul 2027 | Trial primary completion date: Mar 2027 --> Jul 2027 Trial completion date: Oct 2024 --> Feb 2024 | Trial primary completion date: Oct 2024 --> Feb 2024
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, vidutolimod (CMP-001) / Regeneron, Yervoy (ipilimumab) / Ono Pharma, BMS
Journal, Tumor mutational burden, PD(L)-1 Biomarker, IO biomarker, Surgery: Combination Treatment of Intratumoral Vidutolimod, Radiosurgery, Nivolumab, and Ipilimumab for Microsatellite Stable Colorectal Carcinoma With Liver Metastases. (Pubmed Central) - Dec 4, 2023 The combination of intratumoral vidutolimod, radiosurgery, nivolumab and ipilimumab was not found to be efficacious in MSS mCRC with liver metastases. The juxtaposition of liver irradiation and intratumoral vidutolimod injection was associated with high hepatic toxicity.
- |||||||||| ivuxolimab (PF-04518600) / Pfizer, PD 360324 / Pfizer, utomilumab (PF-05082566) / Pfizer
Trial termination, Combination therapy, IO biomarker, Metastases: A Study Of Avelumab In Combination With Other Cancer Immunotherapies In Advanced Malignancies (JAVELIN Medley) (clinicaltrials.gov) - May 8, 2023 P1b/2, N=405, Terminated, Active, not recruiting --> Terminated; The study was terminated since there was no need for further safety or efficacy data to be collected. The participants having benefit from the Investigational treatments have been moved to a continuation study (NCT05059522)
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), vidutolimod (CMP-001) / Regeneron
Trial completion date, Trial primary completion date: CMP-001 for Relapsed and Refractory Lymphoma (clinicaltrials.gov) - Apr 14, 2023 P1/2, N=39, Recruiting, Active, not recruiting --> Completed Trial completion date: Apr 2024 --> Apr 2026 | Trial primary completion date: Apr 2023 --> Apr 2025
- |||||||||| INCAGN1949 / Incyte, vidutolimod (CMP-001) / Regeneron
Enrollment change, Trial completion date, Trial termination, Trial primary completion date, Combination therapy, Metastases: CMP-001 and INCAGN01949 for Patients With Stage IV Pancreatic Cancer and Other Cancers Except Melanoma (clinicaltrials.gov) - Mar 22, 2023 P1/2, N=2, Terminated, Trial completion date: Nov 2024 --> Dec 2025 | Trial primary completion date: Nov 2024 --> Dec 2025 N=42 --> 2 | Trial completion date: Apr 2024 --> Dec 2022 | Recruiting --> Terminated | Trial primary completion date: Apr 2023 --> Dec 2022; Study drug no longer available
- |||||||||| vidutolimod (CMP-001) / Regeneron, Tecentriq (atezolizumab) / Roche
Journal, Combination therapy, Metastases: Vidutolimod in Combination With Atezolizumab With and Without Radiation Therapy in Patients (Pubmed Central) - Mar 17, 2023 P1b In the two patients with initial tumor shrinkage in part A, a strong serum induction of C-X-C motif chemokine ligand 10 was observed. Vidutolimod and atezolizumab with and without RT had a manageable safety profile, with minimal clinical activity in heavily pretreated patients with programmed cell death protein 1 or programmed death-ligand 1 blockade-resistant NSCLC.
- |||||||||| Ampligen (rintatolimod) / AIM ImmunoTech, vidutolimod (CMP-001) / Regeneron
Journal: Trial watch: Toll-like receptor ligands in cancer therapy. (Pubmed Central) - Mar 7, 2023 Solid preclinical and translational results support the favorable immune-activating effects of TLR agonists. Here, we summarize recent preclinical and clinical advances in the development of TLR agonists for anticancer immunotherapy.
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