 |
0 Diseases |  |
1 Trial |
|
1 Trial |  |
4 News |  |
| 12» |
- | autogene cevumeran (RG6180) / Roche, Tecentriq (atezolizumab) / Roche
Journal, PD(L)-1 Biomarker, IO biomarker: RNA neoantigen vaccines prime long-lived CD8+ T cells in pancreatic cancer. (Pubmed Central) - Mar 27, 2025
At an extended 3.2-year median follow-up from a phase 1 trial of surgery, atezolizumab (PD-L1 inhibitory antibody), autogene cevumeran1 (individualized neoantigen vaccine with backbone-optimized uridine mRNA-lipoplex nanoparticles) and modified (m) FOLFIRINOX (chemotherapy) in patients with PDAC, we find that responders with vaccine-induced T cells (n?=?8) have prolonged recurrence-free survival (RFS; median not reached) compared with non-responders without vaccine-induced T cells (n?=?8; median RFS 13.4 months; P??=??0.007)...Thus, in PDAC, autogene cevumeran induces de novo CD8+ T cells with multiyear longevity, substantial magnitude and durable effector functions that may delay PDAC recurrence. Adjuvant mRNA-lipoplex neoantigen vaccines may thus solve a pivotal obstacle for cancer vaccination.
- The building of a cancer vaccine trial platform: The NHS England Cancer Vaccine Launch Pad (CVLP) (Section 50; Poster Board No: 15) - Mar 25, 2025 - Abstract #AACR2025AACR_7845;
Adjuvant mRNA-lipoplex neoantigen vaccines may thus solve a pivotal obstacle for cancer vaccination. Abstract is embargoed at this time.
- ||| autogene cevumeran (RG6180) / Roche
Trial initiation date: IMCODE-004: A Study to Evaluate the Efficacy and Safety of Autogene Cevumeran With Nivolumab Versus Nivolumab Alone in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (MIUC) (clinicaltrials.gov) - Feb 26, 2025
P2, N=362, Recruiting, Sponsor: Hoffmann-La Roche
Abstract is embargoed at this time. Initiation date: Jul 2024 --> Dec 2024
- ||| autogene cevumeran (RG6180) / Roche
Trial completion, Trial completion date, Trial primary completion date: IMCODE001: A Study to Evaluate the Efficacy and Safety of Autogene Cevumeran (RO7198457) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Participants With Previously Untreated Advanced Melanoma. (clinicaltrials.gov) - Feb 7, 2025
P2, N=131, Completed, Sponsor: Genentech, Inc.
Initiation date: Jul 2024 --> Dec 2024 Active, not recruiting --> Completed | Trial completion date: Oct 2025 --> Jan 2025 | Trial primary completion date: Oct 2025 --> Jan 2025
- autogene cevumeran (RG6180) / Roche, Opdivo (nivolumab) / BMS
A randomised, double-blind Phase II study of autogene cevumeran + nivolumab (nivo) vs nivo as adjuvant therapy for patients with high-risk muscle-invasive urothelial carcinoma (MIUC) (Green Area, Retiro) - Jan 13, 2025 - Abstract #EAU2025EAU_949;
- | autogene cevumeran (RG6180) / Roche, Tecentriq (atezolizumab) / Roche
Trial completion date, Trial primary completion date: Study of Personalized Tumor Vaccines (PCVs) and a PD-L1 Blocker in Patients With Pancreatic Cancer That Can be Treated With Surgery (clinicaltrials.gov) - Dec 20, 2024
P1, N=29, Active, not recruiting, Sponsor: Memorial Sloan Kettering Cancer Center
Active, not recruiting --> Completed | Trial completion date: Oct 2025 --> Jan 2025 | Trial primary completion date: Oct 2025 --> Jan 2025 Trial completion date: Nov 2024 --> Nov 2025 | Trial primary completion date: Nov 2024 --> Nov 2025
- ||| autogene cevumeran (RG6180) / Roche
Enrollment change, Trial completion date, Trial primary completion date: BNT122-01: A Phase II Clinical Trial Comparing the Efficacy of RO7198457 Versus Watchful Waiting in Patients with CtDNA-positive, Resected Stage II (high Risk) and Stage III Colorectal Cancer (clinicaltrials.gov) - Dec 3, 2024
P2, N=327, Recruiting, Sponsor: BioNTech SE
Trial completion date: Nov 2024 --> Nov 2025 | Trial primary completion date: Nov 2024 --> Nov 2025 N=229 --> 327 | Trial completion date: Jul 2027 --> Aug 2030 | Trial primary completion date: Feb 2026 --> Nov 2026
- || autogene cevumeran (RG6180) / Roche, Tecentriq (atezolizumab) / Roche
Trial completion date, Trial primary completion date, Combination therapy, Metastases: GO39733: A Study of Autogene Cevumeran (RO7198457) as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Tumors (clinicaltrials.gov) - Nov 6, 2024
P1, N=272, Active, not recruiting, Sponsor: Genentech, Inc.
N=229 --> 327 | Trial completion date: Jul 2027 --> Aug 2030 | Trial primary completion date: Feb 2026 --> Nov 2026 Trial completion date: Nov 2024 --> Mar 2025 | Trial primary completion date: Nov 2024 --> Mar 2025
- |||| autogene cevumeran (RG6180) / Roche
Enrollment open: IMCODE-004: A Study to Evaluate the Efficacy and Safety of Autogene Cevumeran With Nivolumab Versus Nivolumab Alone in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (MIUC) (clinicaltrials.gov) - Aug 9, 2024
P2, N=362, Recruiting, Sponsor: Hoffmann-La Roche
Trial completion date: Nov 2024 --> Mar 2025 | Trial primary completion date: Nov 2024 --> Mar 2025 Not yet recruiting --> Recruiting
- ||||| autogene cevumeran (RG6180) / Roche
New P2 trial: IMCODE-004: A Study to Evaluate the Efficacy and Safety of Autogene Cevumeran With Nivolumab Versus Nivolumab Alone in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (MIUC) (clinicaltrials.gov) - Aug 2, 2024
P2, N=362, Not yet recruiting, Sponsor: Hoffmann-La Roche
- || autogene cevumeran (RG6180) / Roche, Tecentriq (atezolizumab) / Roche
Trial completion date, Trial primary completion date: IMCODE003: A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected PDAC (clinicaltrials.gov) - Apr 25, 2024
P2, N=260, Recruiting, Sponsor: Genentech, Inc.
Not yet recruiting --> Recruiting Trial completion date: May 2029 --> Dec 2029 | Trial primary completion date: May 2029 --> Dec 2029
- autogene cevumeran (RG6180) / Roche
Characterization of T cell responses induced by the individualized mRNA neoantigen vaccine autogene cevumeran in adjuvant stage II (high risk)/stage III colorectal cancer patients from the biomarker cohort of the phase 2 BNT122-01 trial. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5748;
P2
Trial completion date: May 2029 --> Dec 2029 | Trial primary completion date: May 2029 --> Dec 2029 Clinical Trial Registration Number: NCT04486378
- autogene cevumeran (RG6180) / Roche
Preliminary results correlating post-operative ctDNA status with disease-free survival in patients with stage II (high risk)/III colorectal cancer in the BNT000-001 epidemiology study. (Hall A; Poster Bd #: 189) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2596;
P, P2
This study supports existing evidence of the prognostic value of post-operative ctDNA in CRC pts. In ctDNA positive pts, the 12-month DFS rate was almost halved (55% vs. 92% in ctDNA negative).
- | autogene cevumeran (RG6180) / Roche
Journal, IO biomarker: Current and future genomic applications for surgeons. (Pubmed Central) - Mar 31, 2024
The BNT122-01 trial is recruiting patients with ctDNA-positive high-risk colorectal cancer after surgery to assess the impact of cancer vaccines...Immunotherapy, ctDNA, pharmacogenomics, vaccines, mainstreaming and whole-genome sequencing are just some of the innovations that have the potential to redefine the standards of care. The continued exploration of these innovative diagnostics and therapies, the genomic pathway evolution and their application in diverse cancer types highlights the transformative impact of precision medicine in surgery.
- | autogene cevumeran (RG6180) / Roche, Tecentriq (atezolizumab) / Roche
Phase classification, Combination therapy, Metastases: GO39733: A Study of Autogene Cevumeran (RO7198457) as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Tumors (clinicaltrials.gov) - Feb 15, 2024
P1, N=272, Active, not recruiting, Sponsor: Genentech, Inc.
The continued exploration of these innovative diagnostics and therapies, the genomic pathway evolution and their application in diverse cancer types highlights the transformative impact of precision medicine in surgery. Phase classification: P1a/1b --> P1
- || autogene cevumeran (RG6180) / Roche
Trial completion date, Trial primary completion date: IMCODE001: A Study to Evaluate the Efficacy and Safety of Autogene Cevumeran (RO7198457) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Participants With Previously Untreated Advanced Melanoma. (clinicaltrials.gov) - Nov 18, 2023
P2, N=131, Active, not recruiting, Sponsor: Genentech, Inc.
Phase classification: P1a/1b --> P1 Trial completion date: Jun 2024 --> Oct 2025 | Trial primary completion date: Jun 2024 --> Oct 2025
- || autogene cevumeran (RG6180) / Roche
Trial primary completion date: BNT122-01: A Phase II Clinical Trial Comparing the Efficacy of RO7198457 Versus Watchful Waiting in Patients with CtDNA-positive, Resected Stage II (high Risk) and Stage III Colorectal Cancer (clinicaltrials.gov) - Oct 24, 2023
P2, N=201, Recruiting, Sponsor: BioNTech SE
Trial completion date: Jun 2024 --> Oct 2025 | Trial primary completion date: Jun 2024 --> Oct 2025 Trial primary completion date: Sep 2023 --> Feb 2026
- || autogene cevumeran (RG6180) / Roche, Tecentriq (atezolizumab) / Roche
Trial completion date, Trial primary completion date, Combination therapy, Metastases: GO39733: A Study of Autogene Cevumeran (RO7198457) as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Tumors (clinicaltrials.gov) - Aug 21, 2023
P1a/1b, N=272, Active, not recruiting, Sponsor: Genentech, Inc.
Trial primary completion date: Sep 2023 --> Feb 2026 Trial completion date: Sep 2023 --> Nov 2024 | Trial primary completion date: Sep 2023 --> Nov 2024
- ||||| autogene cevumeran (RG6180) / Roche, Tecentriq (atezolizumab) / Roche
New P2 trial: IMCODE003: A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected PDAC (clinicaltrials.gov) - Aug 1, 2023
P2, N=260, Recruiting, Sponsor: Genentech, Inc.
- ||||| mRNA-4157 / Merck (MSD), Moderna, autogene cevumeran (RG6180) / Roche
Clinical: Personalized cancer vaccines pass first major clinical test @NatRevDrugDisc. Comprehensive overview of the current developmental landscape. mRNA-4157 (@moderna_tx / @Merck) Autogene cevumeran (@BioNTech_Group / @genentech) etc. #LCSM @OncoAlert https://t.co/S2bvmiXIGY (Twitter) - Jul 28, 2023
- | autogene cevumeran (RG6180) / Roche
Journal: Personalized mRNA Vaccine Immunogenic against PDAC. (Pubmed Central) - Jul 10, 2023
BioNTech's personalized mRNA vaccine, autogene cevumeran, elicited neoantigen-specific T cells in eight of 16 patients with surgically resected pancreatic ductal adenocarcinoma, leading to T-cell expansion in the bloodstream and delays in disease recurrence, according to phase I trial data. A randomized follow-up study is planned.
- | autogene cevumeran (RG6180) / Roche, Tecentriq (atezolizumab) / Roche
Trial completion date, Trial primary completion date: Study of Personalized Tumor Vaccines (PCVs) and a PD-L1 Blocker in Patients With Pancreatic Cancer That Can be Treated With Surgery (clinicaltrials.gov) - Jul 3, 2023
P1, N=29, Active, not recruiting, Sponsor: Memorial Sloan Kettering Cancer Center
A randomized follow-up study is planned. Trial completion date: Nov 2023 --> Nov 2024 | Trial primary completion date: Nov 2023 --> Nov 2024
- | autogene cevumeran (RG6180) / Roche, Tecentriq (atezolizumab) / Roche
Journal, Tumor-specific neoantigens, PD(L)-1 Biomarker, IO biomarker: Personalized RNA neoantigen vaccines stimulate T cells in pancreatic cancer. (Pubmed Central) - Jun 2, 2023
Trial completion date: Nov 2023 --> Nov 2024 | Trial primary completion date: Nov 2023 --> Nov 2024 After surgery, we sequentially administered atezolizumab (an anti-PD-L1 immunotherapy), autogene cevumeran (a maximum of 20 neoantigens per patient) and a modified version of a
- || autogene cevumeran (RG6180) / Roche, Tecentriq (atezolizumab) / Roche
Trial completion date, Trial primary completion date, Combination therapy, Metastases: GO39733: A Study of Autogene Cevumeran (RO7198457) as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Tumors (clinicaltrials.gov) - Mar 22, 2023
P1a/1b, N=272, Active, not recruiting, Sponsor: Genentech, Inc.
After surgery, we sequentially administered atezolizumab (an anti-PD-L1 immunotherapy), autogene cevumeran (a maximum of 20 neoantigens per patient) and a modified version of a Trial completion date: Jun 2023 --> Sep 2023 | Trial primary completion date: Jun 2023 --> Sep 2023
- || autogene cevumeran (RG6180) / Roche, Tecentriq (atezolizumab) / Roche
Trial completion date, Trial primary completion date, Combination therapy, Metastases: GO39733: A Study of Autogene Cevumeran (RO7198457) as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Tumors (clinicaltrials.gov) - Dec 27, 2022
P1a/1b, N=272, Active, not recruiting, Sponsor: Genentech, Inc.
Trial completion date: Jun 2023 --> Sep 2023 | Trial primary completion date: Jun 2023 --> Sep 2023 Trial completion date: Feb 2024 --> Jun 2023 | Trial primary completion date: Feb 2024 --> Jun 2023
- || autogene cevumeran (RG6180) / Roche
Trial completion date, Trial primary completion date: IMCODE001: A Study to Evaluate the Efficacy and Safety of Autogene Cevumeran (RO7198457) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Participants With Previously Untreated Advanced Melanoma. (clinicaltrials.gov) - Aug 17, 2022
P2, N=131, Active, not recruiting, Sponsor: Genentech, Inc.
Trial completion date: Feb 2024 --> Jun 2023 | Trial primary completion date: Feb 2024 --> Jun 2023 Trial completion date: Sep 2022 --> Apr 2024 | Trial primary completion date: Sep 2022 --> Apr 2024
- ||| autogene cevumeran (RG6180) / Roche
Biomarker, Clinical, Tumor-specific neoantigens, Next-generation sequencing: Correcting self. Yes Individualized! "adjuvant autogene cevumeran containing up to 20 neoantigens in each individualized vaccine, identified from resected PDACs using real-time next generation sequencing and bioinformatic neoantigen discovery https://t.co/4v2halhBEW (Twitter) - Jun 10, 2022
- || Review, Journal: The paradigm shift in treatment from Covid-19 to oncology with mRNA vaccines. (Pubmed Central) - May 26, 2022
In other words, while developing a vaccine design, the underlying motivation should be a reasonable combination of delivery route and format. Exploring various administration routes and delivery route systems has boosted the development of mRNA vaccines.
- | autogene cevumeran (RG6180) / Roche
Journal, Tumor-specific neoantigens: A Fit-for-Purpose Method to Measure Circulating Levels of the mRNA Component of a Liposomal-Formulated Individualized Neoantigen-Specific Therapy for Cancer. (Pubmed Central) - May 10, 2022
Autogene cevumeran is an individualized neoantigen-specific therapy (iNeST) under development for the treatment of various solid tumors...A branched DNA (bDNA)-based mRNA PK assay was developed to achieve the desired assay performance. Here, we discuss the evaluation of various sample collection and processing conditions as well as the optimization of the work flow during bDNA PK method development.
- autogene cevumeran (RG6180) / Roche
Phase I trial of adjuvant autogene cevumeran, an individualized mRNA neoantigen vaccine, for pancreatic ductal adenocarcinoma. (Available On Demand; 172) - Apr 28, 2022 - Abstract #ASCO2022ASCO_1562;
P1
Vaccine induced neoantigen-specific immunity preliminarily correlates with improved PDAC outcome. Further clinical trials in PDAC are warranted.
- autogene cevumeran (RG6180) / Roche
A phase 2 multicenter, open-label, randomized, controlled trial in patients with stage II/III colorectal cancer who are ctDNA positive following resection to compare efficacy of autogene cevumeran versus watchful waiting. (Available On Demand; 428b) - Apr 28, 2022 - Abstract #ASCO2022ASCO_1441;
P2
Key eligibility criteria include 1) Patients must have stage II/III rectal cancer or stage II (high risk)/III colon cancer that has been surgically resected (R0 confirmed by pathology report); 2) patients must be ctDNA positive following resection; and 3) at least 5 tumor neoantigens must be identified in the provided tumor sample for autogene cevumeran manufacturing (RNA lipoplex, RNA-LPX). ClinicalTrials.gov identifier: NCT04486378.
- ||||| autogene cevumeran (RG6180) / Roche
Clinical, Circulating tumor DNA: A Phase II Clinical Trial Comparing the Efficacy of RO7198457 Versus Watchful Waiting in Patients With ctDNA-positive, Resected Stage II (High Risk) and Stage III Colorectal Cancer Twenty-six locations in the US, Belgium, Germany and Spain BioNTech SE https://t.co/cACTTHFhfG (Twitter) - Feb 10, 2022
- || autogene cevumeran (RG6180) / Roche
Enrollment closed: IMCODE001: A Study to Evaluate the Efficacy and Safety of Autogene Cevumeran (RO7198457) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Participants With Previously Untreated Advanced Melanoma. (clinicaltrials.gov) - Feb 3, 2022
P2, N=120, Active, not recruiting, Sponsor: Genentech, Inc.
ClinicalTrials.gov identifier: NCT04486378. Recruiting --> Active, not recruiting
- || autogene cevumeran (RG6180) / Roche, Tecentriq (atezolizumab) / Roche
Enrollment closed, Enrollment change, Combination therapy, Metastases: GO39733: A Study of Autogene Cevumeran (RO7198457) as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Tumors (clinicaltrials.gov) - Jan 27, 2022
P1a/1b, N=272, Active, not recruiting, Sponsor: Genentech, Inc.
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting | N=770 --> 272
- || autogene cevumeran (RG6180) / Roche, Tecentriq (atezolizumab) / Roche
Enrollment closed, Enrollment change: Study of Personalized Tumor Vaccines (PCVs) and a PD-L1 Blocker in Patients With Pancreatic Cancer That Can be Treated With Surgery (clinicaltrials.gov) - Jan 13, 2022
P1, N=29, Active, not recruiting, Sponsor: Memorial Sloan Kettering Cancer Center
Recruiting --> Active, not recruiting | N=770 --> 272 Recruiting --> Active, not recruiting | N=20 --> 29
- | autogene cevumeran (RG6180) / Roche, Tecentriq (atezolizumab) / Roche
Trial completion date, Trial primary completion date: Study of Personalized Tumor Vaccines (PCVs) and a PD-L1 Blocker in Patients With Pancreatic Cancer That Can be Treated With Surgery (clinicaltrials.gov) - Aug 18, 2021
P1, N=20, Recruiting, Sponsor: Memorial Sloan Kettering Cancer Center
Recruiting --> Active, not recruiting | N=20 --> 29 Trial completion date: Nov 2021 --> Nov 2023 | Trial primary completion date: Nov 2021 --> Nov 2023
- | autogene cevumeran (RG6180) / Roche, Tecentriq (atezolizumab) / Roche
Enrollment change, Trial withdrawal, Circulating tumor DNA: A Study of the Efficacy and Safety of RO7198457 in Combination With Atezolizumab Versus Atezolizumab Alone Following Adjuvant Platinum-Doublet Chemotherapy in Participants Who Are ctDNA Positive After Surgical Resection of Stage II-III Non-Small Cell Lung Cancer (clinicaltrials.gov) - Feb 3, 2021
P2, N=0, Withdrawn, Sponsor: Hoffmann-La Roche
Trial completion date: Nov 2021 --> Nov 2023 | Trial primary completion date: Nov 2021 --> Nov 2023 N=80 --> 0 | Recruiting --> Withdrawn
- |||| autogene cevumeran (RG6180) / Roche
Enrollment open: BNT122-01: A Phase II Clinical Trial Comparing the Efficacy of RO7198457 Versus Watchful Waiting in Patients with CtDNA-positive, Resected Stage II (high Risk) and Stage III Colorectal Cancer (clinicaltrials.gov) - Nov 18, 2020
P2, N=201, Recruiting, Sponsor: BioNTech RNA Pharmaceuticals GmbH
N=80 --> 0 | Recruiting --> Withdrawn Not yet recruiting --> Recruiting
- | autogene cevumeran (RG6180) / Roche, Tecentriq (atezolizumab) / Roche
Trial completion date, Trial primary completion date: Study of Personalized Tumor Vaccines (PCVs) and a PD-L1 Blocker in Patients With Pancreatic Cancer That Can be Treated With Surgery (clinicaltrials.gov) - Nov 16, 2020
P1, N=20, Recruiting, Sponsor: Memorial Sloan Kettering Cancer Center
Not yet recruiting --> Recruiting Trial completion date: Nov 2020 --> Nov 2021 | Trial primary completion date: Nov 2020 --> Nov 2021
- || autogene cevumeran (RG6180) / Roche, Tecentriq (atezolizumab) / Roche
Trial initiation date, PD(L)-1 Biomarker, Circulating tumor DNA: A Study of the Efficacy and Safety of RO7198457 in Combination With Atezolizumab Versus Atezolizumab Alone Following Adjuvant Platinum-Doublet Chemotherapy in Participants Who Are ctDNA Positive After Surgical Resection of Stage II-III Non-Small Cell Lung Cancer (clinicaltrials.gov) - Nov 1, 2020
P2, N=80, Recruiting, Sponsor: Hoffmann-La Roche
Trial completion date: Nov 2020 --> Nov 2021 | Trial primary completion date: Nov 2020 --> Nov 2021 Initiation date: Aug 2020 --> Mar 2021
- |||| Clinical: $BNTX Ph1 TNBC-MERIT (mono & combo BNT122) at #ESMO20 $MRK Ph3 Keynote-54 vs placebo Final Data #ESMO20 $BMY Ph1 LSD1 Inh in NHL & BET inh at #ESMO20 $AMGN Ph1 CODEBREAK (amg 510+Keytruda) dose expansion, DoR in NSCLC at #ESMO20 $NVS Ph3 ASCEMBL 3L in CML $AXSM Ph2 AXS05 in MDD (Twitter) - Sep 6, 2020
- || autogene cevumeran (RG6180) / Roche, Tecentriq (atezolizumab) / Roche
Trial completion date, Trial primary completion date, Combination therapy, Metastases: GO39733: A Study of Autogene Cevumeran (RO7198457) as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Tumors (clinicaltrials.gov) - Sep 2, 2020
P1a/1b, N=770, Recruiting, Sponsor: Genentech, Inc.
Initiation date: Aug 2020 --> Mar 2021 Trial completion date: Oct 2020 --> Feb 2024 | Trial primary completion date: Sep 2020 --> Feb 2024
- | autogene cevumeran (RG6180) / Roche
New P2 trial: BNT122-01: A Phase II Clinical Trial Comparing the Efficacy of RO7198457 Versus Watchful Waiting in Patients with CtDNA-positive, Resected Stage II (high Risk) and Stage III Colorectal Cancer (clinicaltrials.gov) - Jul 23, 2020
P2, N=201, Not yet recruiting, Sponsor: BioNTech RNA Pharmaceuticals GmbH
- |||||| RG6180 / Roche, Tecentriq (atezolizumab) / Roche
Clinical, P1 data, Tumor-specific neoantigens: #AACR20 Clinical plenary highlights the phase Ib study of RO7198457, an individualized neoantigen specific immunotherapy (iNeST) with atezolizumab. This represents a personalized immunotherapy approach that designs the agent based on likely neoantigens. #OncoAlert (Twitter) - Jun 23, 2020
- RG6180 / Roche, Tecentriq (atezolizumab) / Roche
[VIRTUAL] A phase Ib study to evaluate RO7198457, an individualized Neoantigen Specific immunoTherapy (iNeST), in combination with atezolizumab in patients with locally advanced or metastatic solid tumors (Virtual Meeting II: All Session Times Are U.S. EDT) - May 16, 2020 - Abstract #AACRII2020AACR-II_4731;
RO7198457 in combination with atezolizumab has a manageable safety profile consistent with the mechanisms of action of the study drugs and induces significant levels of neoantigen-specific immune responses. A randomized Ph2 study of RO7198457 1L melanoma patients in combination with pembrolizumab has been initiated, and two randomized clinical trials are planned for the adjuvant treatment of patients with NSCLC and CRC.
- RG6180 / Roche
A phase Ia study to evaluate RO7198457, an individualized Neoantigen Specific immunoTherapy (iNeST), in patients with locally advanced or metastatic solid tumors (Virtual Meeting II: E-Posters) - May 16, 2020 - Abstract #AACRII2020AACR-II_1812;
RO7198457 has a manageable safety profile consistent with its mechanism of action, and induced strong neoantigen-specific immune responses in patients with low and intermediate mutational load tumors types. A Ph1b study in combination with atezolizumab and a randomized Ph2 study of RO7198457 in 1L melanoma patients with pembrolizumab have been initiated, and two randomized clinical trials are planned in resected lung and CRC.
- ||| autogene cevumeran (RG6180) / Roche, Tecentriq (atezolizumab) / Roche
Enrollment open, PD(L)-1 Biomarker, Circulating tumor DNA: A Study of the Efficacy and Safety of RO7198457 in Combination With Atezolizumab Versus Atezolizumab Alone Following Adjuvant Platinum-Doublet Chemotherapy in Participants Who Are ctDNA Positive After Surgical Resection of Stage II-III Non-Small Cell Lung Cancer (clinicaltrials.gov) - May 11, 2020
P2, N=80, Recruiting, Sponsor: Hoffmann-La Roche
A Ph1b study in combination with atezolizumab and a randomized Ph2 study of RO7198457 in 1L melanoma patients with pembrolizumab have been initiated, and two randomized clinical trials are planned in resected lung and CRC. Not yet recruiting --> Recruiting
- |||| autogene cevumeran (RG6180) / Roche, Tecentriq (atezolizumab) / Roche
New P2 trial, PD(L)-1 Biomarker, Circulating tumor DNA: A Study of the Efficacy and Safety of RO7198457 in Combination With Atezolizumab Versus Atezolizumab Alone Following Adjuvant Platinum-Doublet Chemotherapy in Participants Who Are ctDNA Positive After Surgical Resection of Stage II-III Non-Small Cell Lung Cancer (clinicaltrials.gov) - Feb 11, 2020
P2, N=80, Not yet recruiting, Sponsor: Hoffmann-La Roche
- || autogene cevumeran (RG6180) / Roche, Tecentriq (atezolizumab) / Roche
New P1 trial: Study of Personalized Tumor Vaccines (PCVs) and a PD-L1 Blocker in Patients With Pancreatic Cancer That Can be Treated With Surgery (clinicaltrials.gov) - Nov 14, 2019
P1, N=20, Recruiting, Sponsor: Memorial Sloan Kettering Cancer Center
- || autogene cevumeran (RG6180) / Roche, Tecentriq (atezolizumab) / Roche
Enrollment change, Combination therapy, Metastases: GO39733: A Study of Autogene Cevumeran (RO7198457) as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Tumors (clinicaltrials.gov) - May 3, 2019
P1a/1b, N=770, Recruiting, Sponsor: Genentech, Inc.
Not yet recruiting --> Recruiting N=567 --> 770