CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 100 target
Drug / intervention
ipilimumab +pembrolizumab +durvalumabdrug
Likely dose
ipilimumab +pembrolizumab +durvalumab 2mg/kgfrom record
Key inclusion· 8
  • ✓Cytohistological confirmation required for cancer diagnosis
  • ✓Age above 18 years with estimated survival over 3 months
  • ✓ECOG score less than 2
  • ✓Child-Pugh class A or B
Key exclusion· 13
  • ✕Participated in clinical trials of equipment or drugs within 4 weeks
  • ✕Ascites, hepatic encephalopathy, or esophageal and gastric varices bleeding
  • ✕Serious accompanying disease affecting prognosis: heart disease, inadequately controlled diabetes, psychiatric disorders
  • ✕Other tumors or past medical history of malignancy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05187338
NCT05187338Phase 2RecruitingOn TrackUpdated 24mo ago
Long Recruiting
CompareCT.gov

Triplex CTLA4/PD1/PDL1 Checkpoint Inhibitors Combination Therapy for Advanced Solid Tumors

Second Affiliated Hospital of Guangzhou Medical University·interventional·Posted Jan 11, 2022·Updated Jun 25, 2024

In Brief

A Phase 2 clinical trial evaluating ipilimumab +pembrolizumab +durvalumab for Lung Cancer and 10 related conditions. Currently recruiting, targeting 100 participants across 1 site.

Detailed Summary

This trial is designed to investigate the safety, response rates and survival outcomes of patients with advanced solid tumors by infusion of CTLA4, PD1 and PDL1 antibodies combination through venous (IV), artery (IA) or intra-tumor (IT).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer, Liver Cancer, Colorectal Cancer, Pancreas Cancer, Ovary Cancer, Head and Neck Cancer, Breast Cancer, Gastric Cancer, Cervical Cancer, Esophageal Cancer, Sarcoma
CountriesChina
Collaborators--

Timeline

Phase 2Recruiting
202220232024202520262027202820292030203120322033203420352036
First PostedJan 11, 2022
Enrollment StartNov 1, 2021
Primary CompletionOct 30, 2029
Study CompletionOct 30, 2035
TodayJul 1, 2026
Enrollment to primary: 8.0 yearsPosted 4.5 years agoPrimary completion in 3.3 years

Interventions

ipilimumab +pembrolizumab +durvalumabdrug

This study has 3 subgroups: 1. Ipilimumab +pembrolizumab +durvalumab is administrated with a total dose of 1-2mg/kg via vein, every 3 weeks. 2. Ipilimumab +pembrolizumab +durvalumab is administrated with a total dose of 1-2mg/kg via sustained (10min) micro-pump infusion via artery, every 3 weeks. 3. Ipilimumab +pembrolizumab +durvalumab is administrated with a total dose of 50-150mg via intra-tumor fine needle injection in 5 min, every 3 weeks.