Browse
Submit Data
Databases
API
Help

Dataset Information

0 Views

0 Connections

0 Citations

0 Reanalyses

0 Downloads

Omics score: 0

Pembrolizumab for locally advanced, irresectable, non-metastatic dMMR colorectal cancers. The PUMA study.

ABSTRACT: Primary objectives: To determine the objective response rate (ORR) according to RECIST 1.1 criteria in order to assess the efficacy of pembrolizumab in patients with locally advanced, irresectable dMMR colorectal cancers Primary endpoints: Efficacy of pembrolizumab will be measured by the objective response rate (ORR) according to RECIST 1.1 criteria. The ORR (%) is defined as the proportion of patients with complete response (CR) or partial response (PR) according to RECIST 1.1 as the best observed response to pembrolizumab treatment. All subjects who were treated with at least one cycle of pembrolizumab and underwent subsequent evaluation of their disease will be considered evaluable for response.

DISEASE(S): Colorectal Cancer,Adenocarcinoma Of The Colon Or Rectum

PROVIDER: 2756173 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

ACCESS DATA

Json Xml

Similar Datasets

Differential T-cell and monocyte responses in hepatocellular carcinoma treated with regorafenib plus nivolumab: an integrated clinical and biomarker analysis of the phase 2 RENOBATE trial

Project description:Regorafenib has anti-tumor activity in patients with unresectable hepatocellular carcinoma (uHCC) with potential immunomodulatory effects, suggesting that its combination with immune checkpoint inhibitor may have clinically meaningful benefits in patients with uHCC. The multicenter, single-arm, phase 2 RENOBATE trial tested regorafenib-nivolumab as front-line treatment for uHCC. Forty-two patients received nivolumab 480 mg every 4 weeks and regorafenib 80 mg daily (3-weeks-on/1-week-off schedule). The primary endpoint was the investigator-assessed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The secondary endpoints included safety, progression-free survival (PFS) and overall survival (OS). ORR per RECIST version 1.1 was 31.0%, meeting the primary endpoint. The most common adverse events were palmar-plantar erythrodysesthesia syndrome (38.1%), alopecia (26.2%) and skin rash (23.8%). Median PFS was 7.38 months. The 1-year OS rate was 80.5%, and the median OS was not reached. Exploratory single-cell RNA sequencing analyses of peripheral blood mononuclear cells showed that long-term responders exhibited T cell receptor repertoire diversification, enrichment of genes representing immunotherapy responsiveness in MKI67+ proliferating CD8+ T cells and a higher probability of M1-directed monocyte polarization. Our data support further clinical development of the regorafenib-nivolumab combination as front-line treatment for uHCC and provide preliminary insights on immune biomarkers of response. ClinicalTrials.gov identifier: NCT04310709 .

2023-12-31 | GSE243572 | GEO

A Study of E7386 in Combination With Pembrolizumab in Previously Treated Participants With Selected Solid Tumors

Project description:The Phase 1b part of this study is conducted to assess the safety and tolerability of E7386 in combination with pembrolizumab in participants with previously treated selected solid tumors, and to determine the recommended Phase 2 dose (RP2D) of E7386 in combination with pembrolizumab. The Phase 2 part of this study is conducted to assess the objective response rate (ORR) of E7386 in combination with pembrolizumab (melanoma, colorectal cancer [CRC], hepatocellular carcinoma [HCC]) or of E7386 in combination with pembrolizumab plus lenvatinib (HCC) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

| 2393260 | ecrin-mdr-crc

A PHASE 2, MULTICENTER, OPEN-LABEL STUDY OF DS-8201A IN SUBJECTS WITH HER2-EXPRESSING ADVANCED COLORECTAL CANCER[DESTINY-CRC01]

Project description:Primary objectives: To determine the objective response rate (ORR) of DS-8201a in HER2 - positive advanced metastatic colorectal cancer patients. (Cohort A). Primary endpoints: Objective response rate (ORR) per imaging assessment - Percentage of participants with objective response per independent central imaging facility review based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1

| 2553617 | ecrin-mdr-crc

CAPRI 2 GOIM study: investigate the efficacy and safety of a biomarker-driven cetuximab-based treatment regimen over 3 treatment lines in mCRC patients with RAS/BRAF wt tumors at start of first line.

Project description:Primary objectives: Response Rate (RR) per each line of therapy: assessed according to RECIST criteria 1.1 Primary endpoints: Response Rate (RR) per each line of therapy assessed according to RECIST criteria 1.1

| 2540493 | ecrin-mdr-crc

Randomised study to investigate FOLFOXIRI plus Cetuximab or FOLFOXIRI plus bevacizumab as first-line treatment of BRAF-mutated metastatic colorectal cancer (FIRE 4.5)

Project description:Primary objectives: To compare the objective response rate (ORR) according to RECIST 1.1 of treatment with FOLFOXIRI plus cetuximab versus treatment with FOLFOXIRI plus bevacizumab in BRAF-mutated patients.

| 2535112 | ecrin-mdr-crc

FOLFOXIRI plus Panitumumab or FOLFOX plus Panitumumab in the treatment of metastatic colorectal cancer.

Project description:Primary objectives: compare the activity of panitumumab in combination with mFOLFOX6 or with mFOLFOXIRI in RAS and BRAF wt mCRC patients in terms of Overall Response Rate according to RECIST version 1.1 Primary endpoints: Distribution of overall response rate (ORR)ORR is defined as the percentage of patients, relative to the total of enrolled subjects, achieving a complete (CR) or partial (PR) response, according to RECIST 1.1 criteria, during the induction and the maintenance phases of treatment. The determination of clinical response will be based on investigator reported measurements. Responses will be evaluated every 8 weeks.

| 2536351 | ecrin-mdr-crc

Study of efficacy and safety of laparoscopic intra -abdominal chemotherapy performed in patients with peritoneal carcinomatosis from colorectal , ovarian, gastric cancer and primary peritoneal tumors.

Project description:Primary objectives: Cohort A: - To evaluate the efficacy of PIPAC according to the Overall Response Rate (ORR) in peritoneal carcinomatosis (CP) from colorectal, ovarian, gastric cancers and primary peritoneal tumors.Cohort B- To determine the maximum tolerated dose of oxaliplatin o cisplatin and doxorubicin by PIPAC- To evaluate safety and tolerability of oxaliplatin o cisplatin and doxorubicin by PIPAC Primary endpoints: Overall Response Rate (ORR) according to RECIST criteria (version 1.1)

| 2534264 | ecrin-mdr-crc

Durvalumab (MEDI4736) with or without tremelimumab in MSS and MSI colorectal and endometrial tumors

Project description:Primary objectives: To assess the antitumor activity of Durvalumab or Tremelimumab 300 mg single dose followed by Durvalumab in patients with microsatellite instable (MSI) colorectal cancer (CRC) or endometrial cancer (EC) and Tremelimumab 300 mg single dose followed by Durvalumab in refractory microsatellite stable (MSS) CRC and EC as defined by objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Primary endpoints: Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, and iRECIST if applicable, in patients with advanced, immune naïve MSS CRC, MSS EC, MSI CRC and MSI EC.

| 2735605 | ecrin-mdr-crc

Ph 1-2 Study ADI-PEG 20 Plus FOLFOX in Subjects With Advanced GI Malignancies Focusing on Hepatocellular Carcinoma

Project description:Phase 1: Assessment of safety and tolerability of ADI-PEG 20 in combination with folinic acid (leucovorin), fluorouracil and oxaliplatin (FOLFOX) in advanced GI malignancies. Phase 2: Assessment of the objective response rate (ORR), measured by RECIST 1.1 criteria as assessed by blinded independent central review (BICR).

| 2163812 | ecrin-mdr-crc

Pembrolizumab for Locally Advanced, Irresectable, Non-metastatic dMMR Colorectal Cancers

Project description:In this study, the efficacy of pembrolizumab in patients with locally advanced, irresectable dMMR colorectal cancer will be assessed.

| 2396381 | ecrin-mdr-crc

OmicsDI is part of the ELIXIR infrastructure

OmicsDI is an Elixir interoperability service. Learn more ›

Tweets

OmicsDI Databases

PRIDE
PeptideAtlas
MassIVE
JPOST Repository
Physiome Model Repository

EGA
EVA
ENA
LINCS
PAXDB
Cell Collective

MetaboLights
Metabolomics Workbench
MetabolomeExpress
GNPS
BioModels
FAIRDOMHub

ArrayExpress
dbGaP
ExpressionAtlas
GEO
NODE

Information

Databases
Help
API
Contact us
Code on GitHub
Terms of use
Submit Data