Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04083599 · ClinicalTrials.gov registry record · Phase 1
GEN1042 Safety Trial and Anti-tumor Activity in Participants With Malignant Solid Tumors
A Phase 1 study of Melanoma and Non-small Cell Lung Cancer (NSCLC), sponsored by Genmab.
- Active
- Registry status
- Phase 1
- Development phase
- 350
- Enrollment target
- 20
- Study locations
NCT04083599: Active Phase 1 study of Melanoma and Non-small Cell Lung Cancer (NSCLC), sponsored by Genmab.
NCT04083599 is a Phase 1 study of Melanoma and Non-small Cell Lung Cancer (NSCLC) that is active but no longer recruiting, run by Genmab. The registered enrollment target is 350 participants, below the 705-participant average among 266 other Melanoma trials with a reported enrollment target (50% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04083599, a Phase 1 study of Melanoma and Non-small Cell Lung Cancer (NSCLC), is active but no longer recruiting, sponsored by Genmab.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 350 participants
- Enrollment target
- 20
- Study locations
Study Summary
The goal of this trial is to learn about the antibody GEN1042 when it is used alone and when it is used together with another antibody cancer drug, pembrolizumab (with or without chemotherapy), for treatment of participants with certain types of cancer.
Primary Outcome
Toxicities will be graded for severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria version 5.0
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Carboplatin
- DRUG Cisplatin
- DRUG 5-FU
- BIOLOGICAL GEN1042
Study Locations (20)
California
- Cancer & Blood Specialty Clinic - Los Alamitos
- Moores Cancer Center at the UC San Diego Health - San Diego
Florida
- Mount Sinai Comprehensive Cancer Center - Miami Beach
- Florida Cancer Affiliates - Ocala
Kentucky
- University of Kentucky - Lexington
- Norton Cancer Institute - Louisville
North Carolina
- Levine Cancer Center - Charlotte
- Novant Health Cancer Institute - Forsyth (Medical Oncology) - Winston-Salem
Pennsylvania
- University of Pennsylvania - Philadelphia
- Fox Chase Cancer Center - Philadelphia
Alaska
- Alaska Oncology and Hematology LLC - Anchorage
Connecticut
- Yale University Cancer Center - New Haven
Delaware
- ChristianaCare - Newark
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 350 participants |
| Start Date | 2019-09-17 |
| Est. Completion | 2026-11 |
| Phase | Phase 1 |
What the registry record for NCT04083599 still lists
NCT04083599 is an interventional study that assigns participants to a tested intervention. The registered 350 participants enrollment target is mid-sized for trials with a published cap, below the 705-participant average among 266 other Melanoma trials with a reported enrollment target (50% lower).
The record links to 6 conditions, with Melanoma appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT04083599 names 20 study sites across 15 states, led by California, Florida, Kentucky.
Frequently Asked Questions
What is clinical trial NCT04083599 about?
NCT04083599 is a clinical study titled "GEN1042 Safety Trial and Anti-tumor Activity in Participants With Malignant Solid Tumors". The goal of this trial is to learn about the antibody GEN1042 when it is used alone and when it is used together with another antibody cancer drug, pembrolizumab (with or without chemotherapy), for treatment of participants with certain types of cancer.
What is the current status of trial NCT04083599?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 350 participants. The study started on 2019-09-17. Estimated completion is 2026-11.
What conditions does trial NCT04083599 study?
This clinical trial studies the following conditions: Melanoma, Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma (PDAC), Head and Neck Squamous Cell Carcinoma (HNSCC).
What interventions are being tested in trial NCT04083599?
The interventions under investigation include: Pembrolizumab (DRUG), Carboplatin (DRUG), Cisplatin (DRUG), 5-FU (DRUG), GEN1042 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04083599?
This trial is sponsored by Genmab, which has 45 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04083599 being conducted?
This trial has 20 study locations across Alaska, California, Connecticut, Delaware, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Melanoma
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 NCT04083599's enrollment target sits among peer trials
350 48th of 266 higher than 218 of 266 other Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Melanoma 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
-
Ulixertinib/Palbociclib in Patients With Advanced Pancreatic and Other Solid Tumors
RECRUITING · Phase 1
-
A Study of MQ710 With and Without Pembrolizumab in People With Solid Tumor Cancer
RECRUITING · Phase 1
-
Study of Autologous Tumor-Infiltrating Lymphocytes in Pediatric, Adolescent, and Young Adult Participants
RECRUITING · Phase 1
-
A Study to Investigate the Safety and Efficacy of NST-628 Oral Tablets in Subjects With Solid Tumors
RECRUITING · Phase 1
-
A Study to Learn About the Study Medicine Called PF-07799544 as Monotherapy or in Combination in People With Advanced Solid Tumors
RECRUITING · Phase 1
-
BI-1808 as a Single Agent and With Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20)
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
- NCT00900575 · 350 participants · NA
Cervical Cancer Detection Using Optical Spectroscopy
- NCT01627821 · 350 participants · NA
Evaluation of the Jarvik 2000 Left Ventricular Assist System With Post-Auricular Connector--Destination Therapy Study
- NCT02357654 · 350 participants · Phase 4
GnRH for Luteal Support in IVF/ICSI/FET Cycles
- NCT03997370 · 350 participants · Phase 1
Evaluation of Dosing Procedures of Chemotherapy Treatment (Carboplatin) With the Contrast Agent Iohexol
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- 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