Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04577014 · ClinicalTrials.gov registry record · Phase 1
Retifanlimab (Anti-PD-1 Antibody) With Gemcitabine and Docetaxel in Patients With Advanced Soft Tissue Sarcoma
A Phase 1 study of Sarcoma and Soft Tissue Sarcoma, sponsored by Memorial Sloan Kettering Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 98
- Enrollment target
- 1
- Study location
NCT04577014: Recruiting Phase 1 study of Sarcoma and Soft Tissue Sarcoma, sponsored by Memorial Sloan Kettering Cancer Center.
NCT04577014 is a Phase 1 study of Sarcoma and Soft Tissue Sarcoma that is actively recruiting participants, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 98 participants, below the 920-participant average among 122 other Sarcoma trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04577014, a Phase 1 study of Sarcoma and Soft Tissue Sarcoma, is actively recruiting participants, sponsored by Memorial Sloan Kettering Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 98 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is being done to find out whether the study drug Retifanlimab, a monoclonal antibody against the PD-1 protein, combined with gemcitabine and docetaxel, is a safe and effective treatment for your disease. Gemcitabine and docetaxel are chemotherapy drugs that are commonly used to treat soft tissue sarcoma. Retifanlimab is an experimental drug that boosts the immune system's ability to fight cancer cells. The study researchers think that Retifanlimab may help gemcitabine and docetaxel work better against soft tissue sarcoma that is either locally advanced or has spread beyond its original location (metastasized), and it cannot be removed with surgery (unresectable).
Primary Outcome
The primary objective of the phase II portion of this study is to determine the proportion of patients that are progression-free at 24 weeks by RECIST v1.1. Progressive disease is declared when there is an increase in sum of target disease ≥ 20%, stable disease when the change is \> -30% and ≤ 20%, partial response when there is a decrease in sum of target disease ≥ 30%, and complete response when all lesions have disappeared or all lesions have disappeared and all nodal disease is \< 10 mm each
Conditions Studied
Interventions
- DRUG Docetaxel
- DRUG Retifanlimab
- DRUG Gemcitabine
Study Locations (1)
New York
- Memorial Sloan Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2020-09-29 |
| Est. Completion | 2026-09-29 |
| Phase | Phase 1 |
What NCT04577014 shows while recruiting
NCT04577014 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 920-participant average among 122 other Sarcoma trials with a reported enrollment target (89% lower).
The record links to 4 conditions, with Sarcoma appearing as the primary indexed condition, and to 3 interventions - of which Docetaxel is the first listed.
NCT04577014 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04577014 about?
NCT04577014 is a clinical study titled "Retifanlimab (Anti-PD-1 Antibody) With Gemcitabine and Docetaxel in Patients With Advanced Soft Tissue Sarcoma". This study is being done to find out whether the study drug Retifanlimab, a monoclonal antibody against the PD-1 protein, combined with gemcitabine and docetaxel, is a safe and effective treatment for your disease. Gemcitabine and docetaxel are chemotherapy drugs that are commonly used to treat soft...
What is the current status of trial NCT04577014?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 98 participants. The study started on 2020-09-29. Estimated completion is 2026-09-29.
What conditions does trial NCT04577014 study?
This clinical trial studies the following conditions: Sarcoma, Soft Tissue Sarcoma, Sarcoma,Soft Tissue, Soft Tissue Sarcoma Adult.
What interventions are being tested in trial NCT04577014?
The interventions under investigation include: Docetaxel (DRUG), Retifanlimab (DRUG), Gemcitabine (DRUG).
Who is sponsoring clinical trial NCT04577014?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04577014 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Sarcoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04577014's enrollment target sits among peer trials
98 44th of 122 higher than 79 of 122 other Sarcoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sarcoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Palbociclib and Pembrolizumab in Sarcoma
RECRUITING · Phase 1
-
Autologous B7-H3 Chimeric Antigen Receptor T Cells in Relapsed/Refractory Solid Tumors
RECRUITING · Phase 1
-
Phase 1/2 Trial to Evaluate the Safety and Efficacy of PEEL-224 in Combination With Vincristine and Temozolomide in Adolescents and Young Adults With Relapsed or Refractory Sarcomas
RECRUITING · Phase 1
-
64Cu-LNTH-1363S in Patients With Sarcoma or Gastrointestinal Tract Cancer
RECRUITING · Phase 1
-
A Study of MGC026 in Participants With Advanced Solid Tumors
RECRUITING · Phase 1
-
HER2 Chimeric Antigen Receptor (CAR) T Cells in Combination With Checkpoint Blockade in Patients With Advanced Sarcoma
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02926729 · 98 participants · NA
Real-Time Assessment Of Breast Cancer Lumpectomy Specimen Margins With Nonlinear Microscopy
- NCT03382977 · 98 participants · Phase 1
Study to Evaluate Safety, Tolerability, and Optimal Dose of Candidate GBM Vaccine VBI-1901 in Recurrent GBM Subjects
- NCT04817618 · 98 participants · Phase 3
Study of Efficacy and Safety of Iptacopan in Patients With C3 Glomerulopathy.
- NCT04860141 · 98 participants · Phase 4
Efficacy of Preoperative Administration of Gabapentin in 3rd Molar Dental Extraction.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI
- NCT06358040 · started 2026-10 · NA
Opioid Dispenser for Microdiscectomy/Laminectomy