- |||||||||| 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,
Active, not recruiting --> Completed
- |||||||||| 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,
Active, not recruiting --> Completed Trial primary completion date: Dec 2021 --> Dec 2022
- |||||||||| 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.
- |||||||||| 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,
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
- |||||||||| 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,
This first-in-class, first-in-human study of LV305 demonstrated a favorable safety profile, induction of antigen-specific responses, and potential clinical activity in patients with advanced cancer. 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,
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,
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,
N=12 --> 18 Recruiting --> Active, not recruiting | N=18 --> 12
- |||||||||| 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,
Recruiting --> Active, not recruiting | N=18 --> 12 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.
- |||||||||| ID-LV305 / Merck (MSD)
Trial completion, Trial completion date, Trial primary completion date, Metastases: Phase 1 Study of Intradermal LV305 in Patients With Locally Advanced, Relapsed or Metastatic Cancer Expressing NY-ESO-1 (clinicaltrials.gov) - Mar 6, 2019
P1, N=47, Completed,
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. Active, not recruiting --> Completed | Trial completion date: Aug 2020 --> Dec 2018 | Trial primary completion date: Dec 2017 --> Nov 2018
- |||||||||| 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,
Active, not recruiting --> Completed | Trial completion date: Aug 2020 --> Dec 2018 | Trial primary completion date: Dec 2017 --> Nov 2018 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,
Recruiting --> Active, not recruiting | N=248 --> 1 Not yet recruiting --> Recruiting
- |||||||||| 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,
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
- |||||||||| 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,
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,
- |||||||||| ID-LV305 / Merck (MSD)
Enrollment closed, Enrollment change, Trial primary completion date, Metastases: Phase 1 Study of Intradermal LV305 in Patients With Locally Advanced, Relapsed or Metastatic Cancer Expressing NY-ESO-1 (clinicaltrials.gov) - Aug 21, 2017
P1, N=47, Active, not recruiting,
Initiation date: Mar 2018 --> Jun 2018 Recruiting --> Active, not recruiting | N=59 --> 47 | Trial primary completion date: Dec 2018 --> Dec 2017
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