Clinical Trials Logo

Clinical Trial Summary

Describe the safety, tolerability, efficacy and approaches to prescribing prolgolimab in the standard dosing regimen of 1 mg / kg every 2 weeks in patients with advanced melanoma in routine practice. Prolgolimab (Forteca, formerly BCD 100) is an IgG1 anti-PD-1 (programmed cell death protein 1) monoclonal antibody containing the Fc-silencing 'LALA' mutation.


Clinical Trial Description

Describe the safety and tolerability of using Prolgolimab at a standard dosage regimen of 1 mg / kg every 2 weeks. Describe the efficacy of prolgolimab 1 mg / kg every 2 weeks in patients with metastatic or inoperable melanoma in routine practice, based on the following indicators: Progression-free survival (time from first dose of prolgolimab to disease progression or death for any reason); Overall survival (time from receiving the first dose of prolgolimab to death for any reason); Objective response rate (proportion of patients with a complete or partial response to prolgolimab therapy). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05120024
Study type Observational
Source MelanomaPRO, Russia
Contact Kristina Orlova, MD, PhD
Phone +79629359242
Email [email protected]
Status Recruiting
Phase
Start date October 14, 2020
Completion date December 2023

See also
  Status Clinical Trial Phase
Recruiting NCT05039801 - IACS-6274 With or Without Pembrolizumab for the Treatment of Advanced Solid Tumors Phase 1
Recruiting NCT04894994 - FLX475 in Combination With Ipilimumab in Advanced Melanoma Phase 2
Completed NCT01621490 - PH 1 Biomarker Study of Nivolumab and Ipilimumab and Nivolumab in Combination With Ipilimumab in Advanced Melanoma Phase 1
Recruiting NCT05098184 - Study on TIL for the Treatment of Advanced Melanoma Early Phase 1
Completed NCT02177110 - A Translational Systems Medicine Approach to Provide Predictive Capacity for Therapy Response in Advanced or Metastatic Malignant Melanoma
Completed NCT00197912 - Dendritic Cell Based Therapy of Malignant Melanoma Phase 1/Phase 2
Recruiting NCT04165967 - Adoptive Tumor-infiltrating Lymphocyte Transfer With Nivolumab for Melanoma Phase 1
Recruiting NCT04495257 - A Study of APX005M in Combination With Nivolumab and Ipilimumab in Treatment Naïve Patients With Advanced Melanoma or Renal Cell Carcinoma (RCC) Phase 1
Not yet recruiting NCT03989895 - Arm 2: Intratumoral Injection of Dengue Virus-1 #45AZ5 (PV-001-DV) in Patients With Advanced Melanoma Phase 1
Not yet recruiting NCT03990493 - Arm 3: Intratumoral Injection of PV-001-DV in Combination With Infusion of PV-001-DC in Patients With Advanced Melanoma Phase 1
Active, not recruiting NCT03200847 - Pembrolizumab and All-Trans Retinoic Acid Combination Treatment of Advanced Melanoma Phase 1/Phase 2
Recruiting NCT05105100 - Peripheral T Cell Determinants of Response and Resistance to Pembrolizumab in Melanoma
Completed NCT02171286 - The Oncopanel Pilot (TOP) Study N/A
Terminated NCT01453361 - Phase II FANG™ in Advanced Melanoma Phase 2
Active, not recruiting NCT02965716 - Talimogene Laherparepvec and Pembrolizumab in Treating Patients With Stage III-IV Melanoma Phase 2
Recruiting NCT04514484 - Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV Phase 1
Recruiting NCT05114603 - A Phase II Clinical Trial to Evaluate HLX208 in Advanced Melanoma Patients With BRAF V600 Mutation Phase 2
Not yet recruiting NCT04951583 - Fecal Microbial Transplantation Non-Small Cell Lung Cancer and Melanoma Phase 2
Recruiting NCT02402699 - Ipilimumab 60-month Pharmacovigilance Protocol for Advanced Melanoma Patients Who Are Hepatitis B and/or Hepatitis C Virus Positive in Taiwan N/A
Recruiting NCT01614301 - Phase I and Consecutive Phase II, Two-arm, Randomized Multi-center Trial in Patients With Advanced Melanoma Phase 1/Phase 2