Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
GEN1042 Safety Trial and Anti-tumor Activity in Participants With Malignant Solid Tumors
NCT04083599 · View on ClinicalTrials.gov ↗
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.
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 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04083599
The ClinicalTrials.gov registry entry for NCT04083599 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 350 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genmab, which has 59 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04083599 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Florida, Kentucky. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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, Colorectal Cancer (CRC), Non-Small Cell Lung Cancer (NSCLC), Pancreatic Ductal Adenocarcinoma (PDAC), Head and Neck Squamous Cell Carcinoma (HNSCC). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04083599?
The interventions under investigation include: Pembrolizumab (DRUG), Carboplatin (DRUG), Cisplatin (DRUG), 5-FU (DRUG), GEN1042 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04083599?
This trial is sponsored by Genmab, which has 59 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.