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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04114136
The ClinicalTrials.gov registry entry for NCT04114136 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (90% lower). The listed sponsor is Dan Zandberg, which has 9 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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