CMB305 News - LARVOL Sigma

||||||||||  Proleukin (aldesleukin) / Merck (MSD), Novartis, Iovance Biotherap, ID-LV305 / Merck (MSD), CMB305 / Merck (MSD)
Trial completion, Metastases:  NCI-2018-00926: Modified T Cells, Chemotherapy, and Aldesleukin With or Without LV305 and CMB305 in Treating Participants With Advanced or Recurrent Sarcoma (clinicaltrials.gov) -  Sep 5, 2023
P1, N=15, Completed,  Sponsor: M.D. Anderson Cancer Center
Active, not recruiting --> Completed

|||||||||| Tecentriq (atezolizumab) / Roche, CMB305 / Merck (MSD)
Clinical, P2 data, Journal: Phase II Randomized Study of CMB305 and Atezolizumab Compared With Atezolizumab Alone in Soft-Tissue Sarcomas Expressing NY-ESO-1. (Pubmed Central) - Apr 20, 2022
Although the combination of CMB305 and atezolizumab did not result in significant increases in PFS or OS compared with atezolizumab alone, some patients demonstrated evidence of an anti-NY-ESO-1 immune response and appeared to fare better by imaging than those without such an immune response. Combining prime-boost vaccines such as CMB305 with anti-programmed death ligand-1 therapies merits further evaluation in other clinical contexts.

||||||||||  Proleukin (aldesleukin) / Merck (MSD), Novartis, Iovance Biotherap, ID-LV305 / Merck (MSD), CMB305 / Merck (MSD)
Trial primary completion date, Metastases:  NCI-2018-00926: Modified T Cells, Chemotherapy, and Aldesleukin With or Without LV305 and CMB305 in Treating Participants With Advanced or Recurrent Sarcoma (clinicaltrials.gov) -  Feb 28, 2022
P1, N=15, Active, not recruiting,  Sponsor: M.D. Anderson Cancer Center
Combining prime-boost vaccines such as CMB305 with anti-programmed death ligand-1 therapies merits further evaluation in other clinical contexts. Trial primary completion date: Dec 2021 --> Dec 2022

|||||||||| Tecentriq (atezolizumab) / Roche, CMB305 / Merck (MSD)
Clinical: Phase II Randomized Study of CMB305 and Atezolizumab Compared With Atezolizumab Alone in Soft-Tissue Sarcomas Expressing NY-ESO-1 https://t.co/Tx2Ws25Fzb (Twitter) - Sep 23, 2021

|||||||||| CMB305 / Merck (MSD)
Clinical, P1 data, Journal: A Phase 1b Study Evaluating the Safety, Tolerability, and Immunogenicity of CMB305, a Lentiviral-Based Prime-Boost Vaccine Regimen, in Patients with Locally Advanced, Relapsed, or Metastatic Cancer Expressing NY-ESO-1. (Pubmed Central) - Jul 30, 2021
It is composed of LV305, which is an NY-ESO-1 expressing lentiviral vector, and G305, a recombinant adjuvanted NY-ESO-1 protein...Safety was examined in a 3 + 3 dose-escalation design, followed by an expansion with CMB305 alone or in a combination with either oral metronomic cyclophosphamide or intratumoral injections of a toll-like receptor agonist (glucopyranosyl lipid A)...This is the first trial to test a prime-boost vaccine regimen in patients with advanced cancer. This approach is feasible, can be delivered safely, and with evidence of immune response as well as suggestion of clinical benefit.

|||||||||| Tecentriq (atezolizumab) / Roche, CMB305 / Merck (MSD)
Clinical: Phase II Randomized Study of CMB305 and Atezolizumab Compared With Atezolizumab Alone in Soft-Tissue Sarcomas Expressing NY-ESO-1 @Santchawla1 @bvantine1 https://t.co/vnqeFZc0rc (Twitter) - Jul 29, 2021

||||||||||  Proleukin (aldesleukin) / Merck (MSD), Novartis, Iovance Biotherap, ID-LV305 / Merck (MSD), CMB305 / Merck (MSD)
Enrollment closed, Trial completion date, Trial primary completion date, Metastases:  NCI-2018-00926: Modified T Cells, Chemotherapy, and Aldesleukin With or Without LV305 and CMB305 in Treating Participants With Advanced or Recurrent Sarcoma (clinicaltrials.gov) -  May 6, 2021
P1, N=15, Active, not recruiting,  Sponsor: M.D. Anderson Cancer Center
This approach is feasible, can be delivered safely, and with evidence of immune response as well as suggestion of clinical benefit. Recruiting --> Active, not recruiting | Trial completion date: Jun 2021 --> Dec 2022 | Trial primary completion date: Jun 2021 --> Dec 2021

||||||||||  CMB305 / Merck (MSD)
Trial termination, Metastases:  Study to Compare the Safety and Efficacy of CMB305 With Atezolizumab to Atezolizumab Alone in Participants With Sarcoma (IMDZ-C232/V943A-002) (clinicaltrials.gov) -  Jul 7, 2020
P2, N=89, Terminated,  Sponsor: Immune Design
Recruiting --> Active, not recruiting | Trial completion date: Jun 2021 --> Dec 2022 | Trial primary completion date: Jun 2021 --> Dec 2021 Completed --> Terminated; This study did not meet the efficacy objective

||||||||||  CMB305 / Merck (MSD)
Trial termination, Metastases:  Phase 1b Safety Study of CMB305 in Patients With Locally Advanced, Relapsed, or Metastatic Cancer Expressing NY-ESO-1 (clinicaltrials.gov) -  Jul 1, 2020
P1b, N=79, Terminated,  Sponsor: Immune Design
Completed --> Terminated; This study did not meet the efficacy objective Completed --> Terminated; This study did not meet the efficacy objective

||||||||||  Proleukin (aldesleukin) / Merck (MSD), Novartis, Iovance Biotherap, ID-LV305 / Merck (MSD), CMB305 / Merck (MSD)
Enrollment open, Metastases:  NCI-2018-00926: Modified T Cells, Chemotherapy, and Aldesleukin With or Without LV305 and CMB305 in Treating Participants With Advanced or Recurrent Sarcoma (clinicaltrials.gov) -  Mar 23, 2020
P1, N=18, Recruiting,  Sponsor: M.D. Anderson Cancer Center
Completed --> Terminated; This study did not meet the efficacy objective Active, not recruiting --> Recruiting

||||||||||  Proleukin (aldesleukin) / Merck (MSD), Novartis, Iovance Biotherap, ID-LV305 / Merck (MSD), CMB305 / Merck (MSD)
Trial completion date, Trial primary completion date, Metastases:  NCI-2018-00926: Modified T Cells, Chemotherapy, and Aldesleukin With or Without LV305 and CMB305 in Treating Participants With Advanced or Recurrent Sarcoma (clinicaltrials.gov) -  Feb 5, 2020
P1, N=18, Active, not recruiting,  Sponsor: M.D. Anderson Cancer Center
Active, not recruiting --> Recruiting Trial completion date: Dec 2019 --> Jun 2021 | Trial primary completion date: Dec 2019 --> Jun 2021

||||||||||  Proleukin (aldesleukin) / Merck (MSD), Novartis, Iovance Biotherap, ID-LV305 / Merck (MSD), CMB305 / Merck (MSD)
Enrollment change, Metastases:  NCI-2018-00926: Modified T Cells, Chemotherapy, and Aldesleukin With or Without LV305 and CMB305 in Treating Participants With Advanced or Recurrent Sarcoma (clinicaltrials.gov) -  Sep 29, 2019
P1, N=18, Active, not recruiting,  Sponsor: M.D. Anderson Cancer Center
Trial completion date: Dec 2019 --> Jun 2021 | Trial primary completion date: Dec 2019 --> Jun 2021 N=12 --> 18

||||||||||  Proleukin (aldesleukin) / Merck (MSD), Novartis, Iovance Biotherap, ID-LV305 / Merck (MSD), CMB305 / Merck (MSD)
Enrollment closed, Enrollment change, Metastases:  NCI-2018-00926: Modified T Cells, Chemotherapy, and Aldesleukin With or Without LV305 and CMB305 in Treating Participants With Advanced or Recurrent Sarcoma (clinicaltrials.gov) -  Sep 5, 2019
P1, N=12, Active, not recruiting,  Sponsor: M.D. Anderson Cancer Center
N=12 --> 18 Recruiting --> Active, not recruiting | N=18 --> 12

||||||||||  CMB305 / Merck (MSD)
Trial completion, Metastases:  Study to Compare the Safety and Efficacy of CMB305 With Atezolizumab to Atezolizumab Alone in Participants With Sarcoma (IMDZ-C232/V943A-002) (clinicaltrials.gov) -  May 20, 2019
P2, N=88, Completed,  Sponsor: Immune Design
Recruiting --> Active, not recruiting | N=18 --> 12 Active, not recruiting --> Completed

||||||||||  CMB305 / Merck (MSD)
Trial completion, Trial completion date, Trial primary completion date, Metastases:  Phase 1b Safety Study of CMB305 in Patients With Locally Advanced, Relapsed, or Metastatic Cancer Expressing NY-ESO-1 (clinicaltrials.gov) -  May 20, 2019
P1b, N=79, Completed,  Sponsor: Immune Design
Active, not recruiting --> Completed Active, not recruiting --> Completed | Trial completion date: Dec 2019 --> Mar 2019 | Trial primary completion date: Dec 2019 --> Mar 2019

||||||||||  CMB305 / Merck (MSD)
Trial completion date, Trial termination, Trial primary completion date, Metastases:  Synovate: A Phase 3, Randomized, Double-blind, Placebo-controlled Study For Subjects With Locally-advanced Unresectable or Metastatic Synovial Sarcoma (V943-003, IMDZ-04-1702) (clinicaltrials.gov) -  Mar 7, 2019
P3, N=1, Terminated,  Sponsor: Immune Design
Active, not recruiting --> Completed | Trial completion date: Dec 2019 --> Mar 2019 | Trial primary completion date: Dec 2019 --> Mar 2019 Trial completion date: Jun 2023 --> Nov 2018 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2020 --> Nov 2018; Study was terminated due to sponsor's decision.

||||||||||  CMB305 / Merck (MSD)
Trial primary completion date, Metastases:  Study to Compare the Safety and Efficacy of CMB305 With Atezolizumab to Atezolizumab Alone in Participants With Sarcoma (IMDZ-C232/V943A-002) (clinicaltrials.gov) -  Mar 6, 2019
P2, N=88, Active, not recruiting,  Sponsor: Immune Design
Trial completion date: Jun 2023 --> Nov 2018 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2020 --> Nov 2018; Study was terminated due to sponsor's decision. Trial primary completion date: Dec 2018 --> Mar 2019

||||||||||  CMB305 / Merck (MSD)
Enrollment closed, Enrollment change, Metastases:  Synovate: A Phase 3, Randomized, Double-blind, Placebo-controlled Study For Subjects With Locally-advanced Unresectable or Metastatic Synovial Sarcoma (V943-003, IMDZ-04-1702) (clinicaltrials.gov) -  Oct 29, 2018
P3, N=1, Active, not recruiting,  Sponsor: Immune Design
Trial primary completion date: Dec 2018 --> Mar 2019 Recruiting --> Active, not recruiting | N=248 --> 1

||||||||||  Proleukin (aldesleukin) / Merck (MSD), Novartis, Iovance Biotherap, ID-LV305 / Merck (MSD), CMB305 / Merck (MSD)
Enrollment open, Metastases:  NCI-2018-00926: Modified T Cells, Chemotherapy, and Aldesleukin With or Without LV305 and CMB305 in Treating Participants With Advanced or Recurrent Sarcoma (clinicaltrials.gov) -  Sep 18, 2018
P1, N=18, Recruiting,  Sponsor: M.D. Anderson Cancer Center
Recruiting --> Active, not recruiting | N=248 --> 1 Not yet recruiting --> Recruiting

||||||||||  CMB305 / Merck (MSD)
Trial initiation date, Metastases:  Synovate: A Phase 3, Randomized, Double-blind, Placebo-controlled Study For Subjects With Locally-advanced Unresectable or Metastatic Synovial Sarcoma (V943-003, IMDZ-04-1702) (clinicaltrials.gov) -  Aug 24, 2018
P3, N=248, Recruiting,  Sponsor: Immune Design
Not yet recruiting --> Recruiting Initiation date: Jun 2018 --> Sep 2018

||||||||||  Proleukin (aldesleukin) / Merck (MSD), Novartis, Iovance Biotherap, ID-LV305 / Merck (MSD), CMB305 / Merck (MSD)
Trial completion date, Trial initiation date, Trial primary completion date, Metastases:  NCI-2018-00926: Modified T Cells, Chemotherapy, and Aldesleukin With or Without LV305 and CMB305 in Treating Participants With Advanced or Recurrent Sarcoma (clinicaltrials.gov) -  Jul 3, 2018
P1, N=18, Not yet recruiting,  Sponsor: M.D. Anderson Cancer Center
Initiation date: Jun 2018 --> Sep 2018 Trial completion date: Jun 2019 --> Dec 2019 | Initiation date: Jun 2018 --> Sep 2018 | Trial primary completion date: Jun 2018 --> Dec 2019

||||||||||  CMB305 / Merck (MSD)
Trial completion date, Trial primary completion date, Metastases:  Study to Compare the Safety and Efficacy of CMB305 With Atezolizumab to Atezolizumab Alone in Participants With Sarcoma (IMDZ-C232/V943A-002) (clinicaltrials.gov) -  Jun 27, 2018
P2, N=88, Active, not recruiting,  Sponsor: Immune Design
Trial completion date: Jun 2019 --> Dec 2019 | Initiation date: Jun 2018 --> Sep 2018 | Trial primary completion date: Jun 2018 --> Dec 2019 Trial completion date: Jul 2019 --> Mar 2019 | Trial primary completion date: May 2017 --> Dec 2018

||||||||||  CMB305 / Merck (MSD)
Enrollment closed, Metastases:  Phase 1b Safety Study of CMB305 in Patients With Locally Advanced, Relapsed, or Metastatic Cancer Expressing NY-ESO-1 (clinicaltrials.gov) -  Jun 27, 2018
P1b, N=79, Active, not recruiting,  Sponsor: Immune Design
Trial completion date: Jul 2019 --> Mar 2019 | Trial primary completion date: May 2017 --> Dec 2018 Recruiting --> Active, not recruiting

||||||||||  CMB305 / Merck (MSD)
Enrollment open, Metastases:  Synovate: A Phase 3, Randomized, Double-blind, Placebo-controlled Study For Subjects With Locally-advanced Unresectable or Metastatic Synovial Sarcoma (V943-003, IMDZ-04-1702) (clinicaltrials.gov) -  Jun 19, 2018
P3, N=248, Recruiting,  Sponsor: Immune Design
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting

||||||||||  CMB305 / Merck (MSD)
New P3 trial, Metastases:  Synovate: A Phase 3, Randomized, Double-blind, Placebo-controlled Study For Subjects With Locally-advanced Unresectable or Metastatic Synovial Sarcoma (V943-003, IMDZ-04-1702) (clinicaltrials.gov) -  May 11, 2018
P3, N=248, Not yet recruiting,  Sponsor: Immune Design

||||||||||  Proleukin (aldesleukin) / Merck (MSD), Novartis, Iovance Biotherap, ID-LV305 / Merck (MSD), CMB305 / Merck (MSD)
Trial initiation date, Metastases:  NCI-2018-00926: Modified T Cells, Chemotherapy, and Aldesleukin With or Without LV305 and CMB305 in Treating Participants With Advanced or Recurrent Sarcoma (clinicaltrials.gov) -  Apr 12, 2018
P1, N=18, Not yet recruiting,  Sponsor: M.D. Anderson Cancer Center
Not yet recruiting --> Recruiting Initiation date: Mar 2018 --> Jun 2018

||||||||||  Proleukin (aldesleukin) / Merck (MSD), Novartis, Iovance Biotherap, ID-LV305 / Merck (MSD), CMB305 / Merck (MSD)
New P1 trial, Metastases:  NCI-2018-00926: Modified T Cells, Chemotherapy, and Aldesleukin With or Without LV305 and CMB305 in Treating Participants With Advanced or Recurrent Sarcoma (clinicaltrials.gov) -  Mar 1, 2018
P1, N=18, Not yet recruiting,  Sponsor: M.D. Anderson Cancer Center

||||||||||  CMB305 / Merck (MSD)
Enrollment change, Trial primary completion date, Metastases:  Phase 1b Safety Study of CMB305 in Patients With Locally Advanced, Relapsed, or Metastatic Cancer Expressing NY-ESO-1 (clinicaltrials.gov) -  Jul 5, 2017
P1b, N=69, Recruiting,  Sponsor: Immune Design
Initiation date: Mar 2018 --> Jun 2018 N=45 --> 69 | Trial primary completion date: Dec 2017 --> Dec 2019

||||||||||  CMB305 / Merck (MSD)
Enrollment closed, Metastases:  Study to Compare the Safety and Efficacy of CMB305 With Atezolizumab to Atezolizumab Alone in Participants With Sarcoma (IMDZ-C232/V943A-002) (clinicaltrials.gov) -  Jul 2, 2017
P2, N=88, Active, not recruiting,  Sponsor: Immune Design
N=45 --> 69 | Trial primary completion date: Dec 2017 --> Dec 2019 Recruiting --> Active, not recruiting

||||||||||  CMB305 / Merck (MSD)
Phase classification, Metastases:  Phase 1b Safety Study of CMB305 in Patients With Locally Advanced, Relapsed, or Metastatic Cancer Expressing NY-ESO-1 (clinicaltrials.gov) -  Aug 24, 2016
P1b, N=45, Recruiting,  Sponsor: Immune Design
Recruiting --> Active, not recruiting Phase classification: P1 --> P1b

||||||||||  CMB305 / Merck (MSD)
New P2 trial, Metastases:  Study to Compare the Safety and Efficacy of CMB305 With Atezolizumab to Atezolizumab Alone in Participants With Sarcoma (IMDZ-C232/V943A-002) (clinicaltrials.gov) -  Nov 21, 2015
P2, N=80, Recruiting,  Sponsor: Immune Design

||||||||||  CMB305 / Merck (MSD)
Enrollment change, Trial primary completion date, Metastases:  Phase 1b Safety Study of CMB305 in Patients With Locally Advanced, Relapsed, or Metastatic Cancer Expressing NY-ESO-1 (clinicaltrials.gov) -  Aug 21, 2015
P1, N=45, Recruiting,  Sponsor: Immune Design
Phase classification: P1 --> P1b N=33 --> 45 | Trial primary completion date: Aug 2017 --> Dec 2017

||||||||||  CMB305 / Merck (MSD)
New P1 trial, Metastases:  Phase 1b Safety Study of CMB305 in Patients With Locally Advanced, Relapsed, or Metastatic Cancer Expressing NY-ESO-1 (clinicaltrials.gov) -  Mar 12, 2015
P1, N=33, Recruiting,  Sponsor: Immune Design



	Diseases Companies Products Productz Mechanisms of Action Sites