NCT03384836

Propranolol Hydrochloride and Pembrolizumab in Treating Patients With Stage IIIC-IV Melanoma That Cannot Be Removed by Surgery

Suspended Phase 1, PHASE2 Last updated 2 July 2025

What this trial tests

Phase 1, PHASE2 trial testing Laboratory Biomarker Analysis in Stage IIIC Cutaneous Melanoma AJCC v7 in 47 participants. Suspended.

Timeline

31 January 2018

Primary endpoint
31 May 2027

31 May 2027

Quick facts

Lead sponsor	Roswell Park Cancer Institute
Phase	Phase 1, PHASE2
Status	Suspended
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	47
Start date	31 January 2018
Primary completion	31 May 2027
Estimated completion	31 May 2027
Sites	4 locations across United States

Drugs / interventions tested

• Laboratory Biomarker Analysis — full drug profile →
• Pembrolizumab (pembrolizumab) — full drug profile →
• Propranolol Hydrochloride — full drug profile →

Conditions studied

• Stage IIIC Cutaneous Melanoma AJCC v7 — all drugs for Stage IIIC Cutaneous Melanoma AJCC v7 →
• Stage IV Cutaneous Melanoma AJCC v6 and v7 — all drugs for Stage IV Cutaneous Melanoma AJCC v6 and v7 →

Sponsor

Roswell Park Cancer Institute

Who can join

18 and older, any sex, with Stage IIIC Cutaneous Melanoma AJCC v7 or Stage IV Cutaneous Melanoma AJCC v6 and v7. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase Ib/II trial studies the side effects and best dose of propranolol hydrochloride when given together with pembrolizumab and how well they work in treating patients with stage IIIC-IV melanoma that cannot be removed by surgery. Pembrolizumab is a monoclonal antibody that "takes the brakes off the immune system" and thus allows for anti-tumor immune responses. Propranolol hydrochloride is a beta adrenergic blocking agent that can enhance immune cell responses when under stress. Giving propranolol hydrochloride and pembrolizumab may work better in treating patients with melanoma.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The updated landscape of tumor microenvironment and drug repurposing.
   Jin MZ, Jin WL. · · 2020 · cited 900× · PMID 32843638 · DOI 10.1038/s41392-020-00280-x
2. The Evasion Mechanisms of Cancer Immunity and Drug Intervention in the Tumor Microenvironment.
   Kim SK, Cho SW. · · 2022 · cited 300× · PMID 35685630 · DOI 10.3389/fphar.2022.868695
3. Managing Metastatic Melanoma in 2022: A Clinical Review.
   Switzer B, Puzanov I, Skitzki JJ, Hamad L, et al · · 2022 · cited 144× · PMID 35133862 · DOI 10.1200/op.21.00686
4. Phase I Clinical Trial of Combination Propranolol and Pembrolizumab in Locally Advanced and Metastatic Melanoma: Safety, Tolerability, and Preliminary Evidence of Antitumor Activity.
   Gandhi S, Pandey MR, Attwood K, Ji W, et al · · 2021 · cited 107× · PMID 33127652 · DOI 10.1158/1078-0432.ccr-20-2381
5. Therapeutic avenues for cancer neuroscience: translational frontiers and clinical opportunities.
   Shi DD, Guo JA, Hoffman HI, Su J, et al · · 2022 · cited 104× · PMID 35114133 · DOI 10.1016/s1470-2045(21)00596-9
6. Non-Small-Cell Lung Cancer Signaling Pathways, Metabolism, and PD-1/PD-L1 Antibodies.
   Santarpia M, Aguilar A, Chaib I, Cardona AF, et al · · 2020 · cited 80× · PMID 32516941 · DOI 10.3390/cancers12061475
7. Combination Strategies to Augment Immune Check Point Inhibitors Efficacy - Implications for Translational Research.
   Varayathu H, Sarathy V, Thomas BE, Mufti SS, et al · · 2021 · cited 62× · PMID 34123767 · DOI 10.3389/fonc.2021.559161
8. Targeting the peripheral neural-tumour microenvironment for cancer therapy.
   Yaniv D, Mattson B, Talbot S, Gleber-Netto FO, et al · · 2024 · cited 56× · PMID 39242781 · DOI 10.1038/s41573-024-01017-z