Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04114136 · ClinicalTrials.gov registry record · Phase 2
Anti-PD-1 mAb Plus Metabolic Modulator in Solid Tumor Malignancies
A Phase 2 study of Melanoma and Hepatocellular Carcinoma, sponsored by Dan Zandberg.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 72
- Enrollment target
- 1
- Study location
NCT04114136: Recruiting Phase 2 study of Melanoma and Hepatocellular Carcinoma, sponsored by Dan Zandberg.
NCT04114136 is a Phase 2 study of Melanoma and Hepatocellular Carcinoma that is actively recruiting participants, run by Dan Zandberg. The registered enrollment target is 72 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04114136, a Phase 2 study of Melanoma and Hepatocellular Carcinoma, is actively recruiting participants, sponsored by Dan Zandberg.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 72 participants
- Enrollment target
- 1
- Study location
Study Summary
Patients with histologically or cytologically confirmed advanced melanoma, renal cell carcinoma, NSCLC, HCC (Child Pugh Class A only), MSI-High solid tumors, Urothelial Cancer, GE junction/Gastric Adenocarcinoma, or HNSCC for which current standard of care treatment for their stage of disease would be with Pembrolizumab or Nivolumab monotherapy, who meet eligibility criteria will undergo a biopsy (core or excisional/incisional; FNA not adequate) for baseline tissue. Patients will then be randomized to one of 3 arms: Anti-PD-1 mAb plus Metformin 500mg po BID, Anti-PD-1 mAb alone, Anti-PD-1 mAb plus Rosiglitazone 4mg po qdaily. Five weeks (+/- 7 days) after initiation of therapy a patient will undergo a repeat biopsy (core or excisional/incisional; FNA not adequate) for correlative analysis. The patient will then continue on study therapy for up to 2 years, or until progression of disease or unacceptable toxicity, whichever occurs first. RECIST 1.1 with modifications, to allow for continued therapy until progressive disease is confirmed if the patient is clinically stable, will be used in the trial.
Primary Outcome
Best overall response per Response Evaluation Criteria in Solid Tumors (RECIST v1.1), by tumor type, recorded from the start of the treatment until disease progression/recurrence. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to \<10 mm. Partial Response (PR): ≥ 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Incomplete Response/Stable Dis
Conditions Studied
Interventions
- DRUG Nivolumab or Pembrolizumab (dependent upon approved indication)
- DRUG Metformin
- DRUG Rosiglitazone
Study Locations (1)
Pennsylvania
- UPMC Hillman Cancer Center - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2020-09-14 |
| Est. Completion | 2032-04-30 |
| Phase | Phase 2 |
What NCT04114136 shows while recruiting
NCT04114136 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (90% lower).
The record links to 8 conditions, with Melanoma appearing as the primary indexed condition, and to 3 interventions - of which Nivolumab or Pembrolizumab (dependent upon approved indication) is the first listed.
NCT04114136 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04114136 about?
NCT04114136 is a clinical study titled "Anti-PD-1 mAb Plus Metabolic Modulator in Solid Tumor Malignancies". Patients with histologically or cytologically confirmed advanced melanoma, renal cell carcinoma, NSCLC, HCC (Child Pugh Class A only), MSI-High solid tumors, Urothelial Cancer, GE junction/Gastric Adenocarcinoma, or HNSCC for which current standard of care treatment for their stage of disease would ...
What is the current status of trial NCT04114136?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 72 participants. The study started on 2020-09-14. Estimated completion is 2032-04-30.
What conditions does trial NCT04114136 study?
This clinical trial studies the following conditions: Melanoma, Hepatocellular Carcinoma, NSCLC, Gastric Adenocarcinoma, Esophageal Adenocarcinoma.
What interventions are being tested in trial NCT04114136?
The interventions under investigation include: Nivolumab or Pembrolizumab (dependent upon approved indication) (DRUG), Metformin (DRUG), Rosiglitazone (DRUG).
Who is sponsoring clinical trial NCT04114136?
This trial is sponsored by Dan Zandberg, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04114136 being conducted?
This trial has 1 study location across Pennsylvania. 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 NCT04114136's enrollment target sits among peer trials
72 132nd of 266 higher than 133 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
-
Neoadjuvant Immune Checkpoint Blockade + a Prebiotic Food-enriched Dietary Intervention to Optimize Immune Response in Melanoma: NEO-PreFED
RECRUITING · Phase 2
-
Zimberelimab (AB122) With TIGIT Inhibitor Domvanalimab (AB154) in PD-1 Relapsed/Refractory Melanoma
RECRUITING · Phase 2
-
A Study of IBI363 in Subjects with Advanced Solid Malignancies
RECRUITING · Phase 2
-
A Phase 2 Trial for Metastatic Melanoma Using Adoptive Cell Therapy With Tumor Infiltrating Lymphocytes Plus IL-2 Either Alone or Following the Administration of Pembrolizumab
RECRUITING · Phase 2
-
Neoadjuvant and Adjuvant Anti-PD1 or Combinations for Locoregionally Advanced Melanoma
RECRUITING · Phase 2
-
Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Cancer Patients
RECRUITING · Phase 2
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
- NCT02359253 · 72 participants · NA
Robot Aided Rehabilitation - Intervention
- NCT02962661 · 72 participants · Phase 1
Donor Bone Marrow Derived Mesenchymal Stem Cells in Controlling Heart Failure in Patients With Cardiomyopathy Caused by Anthracyclines
- NCT03113643 · 72 participants · Phase 1
SL-401 in Combination With Azacitidine or Azacitidine/Venetoclax in Acute Myeloid Leukemia (AML), High-Risk Myelodysplastic Syndrome (MDS) or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
- NCT03187535 · 72 participants · NA
Effect of TEAS on PONV After Spinal Surgery
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