Clinical trials: Neoadjuvant Melanoma
Melanoma
Neoadjuvant Nivolumab+Ipilimumab Followed by Adjuvant Nivolumab or Neoadjuvant Nivolumab+Ipilimumab Followed by Adjuvant Observation Compared With Adjuvant Nivolumab in Treatment-Naive High-risk Melanoma Participants
The purpose of this study is to evaluate the role of neoadjuvant immunotherapy and to demonstrate high pathologic complete response (pCR) and near pCR rates in melanoma participants with clinically detectable nodal disease and a…
- Trial name
- CheckMate 7UA (NCT04495010)
- Testing
- Nivolumab, Ipilimumab
- Where
- 118 sites in United States, Australia and 14 more
- Sponsor
- Bristol-Myers Squibb
Solid Tumor, Non-Small Cell Lung Cancer
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
This is a Phase 1/2, open-label, non-randomized, 4-part trial to determine the safety profile and identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of INBRX 106 administered as a single agent or in…
- Conditions
- Solid Tumor, Non-Small Cell Lung Cancer, Head and Neck Cancer, Melanoma
- Trial name
- NCT04198766
- Testing
- INBRX-106 - Hexavalent OX40 agonist antibody, pembrolizumab 200 mg, pembrolizumab 400 mg
- Where
- 42 sites in United States, Singapore and 2 more
- Volunteers
- 340 people
- Sponsor
- Inhibrx Biosciences, Inc
Pathologic Stage III Cutaneous Melanoma AJCC v8
Study of Neoadjuvant Imprime PGG and Pembrolizumab for Stage III, Resectable Melanoma
Approximately 50 ABA+ subjects with resectable, Stage III (IIIB, IIIC, or IIID) melanoma will be included in the study and randomized in a 3:2 ratio to neoadjuvant treatment with Imprime PGG plus pembrolizumab vs.
- Trial name
- NCT04995094
- Testing
- Imprime PGG, Pembrolizumab
- Where
- 4 sites in United States
- Sponsor
- HiberCell, Inc.
Advanced Solid Tumor, Locally Advanced Solid Tumor
A Study of TransCon TLR7/8 Agonist With or Without Pembrolizumab in Patients With Advanced or Metastatic Solid Tumors
TransCon TLR7/8 Agonist is an investigational drug being developed for treatment of locally advanced or metastatic solid tumors.
- Conditions
- Advanced Solid Tumor, Locally Advanced Solid Tumor, Metastatic Solid Tumor, Head and Neck Squamous Cell Carcinoma HNSCC
- Trial name
- NCT04799054
- Testing
- TransCon TLR7/8 Agonist, Pembrolizumab
- Where
- 49 sites in United States, Australia and 4 more
- Volunteers
- 188 people
- Sponsor
- Ascendis Pharma Oncology Division A/S
Melanoma Stage III, Melanoma (Skin)
A Study of Neoadjuvant Therapy With BCD-217 (Nurulimab + Prolgolimab) in Patients With Resectable Stage III Skin Melanoma
This study is an open-label, randomized, comparative phase III study, which will include subjects with resectable stage III skin melanoma (up to 3 resectable transient metastases are acceptable).
- Trial name
- NEO-MIMAJOR (NCT05751928)
- Testing
- BCD-217, anti-PD1, Excision of the primary lesion
- Where
- 36 sites in Belarus, Russia
- Volunteers
- 411 people
- Sponsor
- Biocad
Completely Resectable Stage IIIB, IIIC, or IVM1a Melanoma
Efficacy and Safety of Talimogene Laherparepvec Neoadjuvant Treatment Plus Surgery Versus Surgery Alone for Melanoma
This is a phase 2, multicenter, randomized, open-label study to estimate the efficacy of talimogene laherparepvec as a neoadjuvant treatment followed by surgery compared to surgery alone in subjects with completely resectable…
- Trial name
- NCT02211131
- Testing
- Talimogene Laherparepvec, Immediate surgical resection of melanoma lesion(s)
- Where
- 46 sites in United States, Australia and 7 more
- Volunteers
- 150 people
- Sponsor
- Amgen
Uveal Melanoma
Neoadjuvant Darovasertib in Primary Uveal Melanoma
This is a Phase 3, randomized, multi-center, open-label study of neoadjuvant darovasertib in subjects with primary non-metastatic uveal melanoma (OptimUM-10)
- Trial name
- NCT07015190
- Testing
- Darovasertib, Primary Local Therapy
- Where
- 94 sites in United States, Australia and 19 more
- Volunteers
- 520 people
- Sponsor
- IDEAYA Biosciences
Uveal Melanoma
Study of Neoadjuvant RBP-01 In Patients With Primary Uveal Melanoma
Neoadjuvant RBP-01 in patients with primary uveal melanoma.
- Trial name
- Uveal Melanoma (NCT07747935)
- Testing
- RBP-01
- Volunteers
- 30 people
- Sponsor
- ReBio Pharma
Uveal Melanoma
(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma
Neoadjuvant/adjuvant IDE196 (darovasertib) in patients with primary uveal melanoma
- Trial name
- NCT05907954
- Testing
- Darovasertib
- Where
- 18 sites in United States, Australia and 5 more
- Volunteers
- 160 people
- Sponsor
- IDEAYA Biosciences
Melanoma Stage III
The Efficacy and Safety of PRTX007-003 Combined With Pembrolizumab in Resectable Stage III Melanoma
This Phase 2, multi-center, single-arm study evaluates the safety, tolerability, and activity of neoadjuvant PRTX007 in combination with pembrolizumab in participants with resectable Stage III melanoma.
- Trial name
- INFLECTION-003 (NCT07565285)
- Testing
- PRTX007, Pembrolizumab
- Where
- 7 sites in Australia
- Volunteers
- 48 people
- Sponsor
- Primmune Therapeutics, Inc.
Advanced Solid Tumor, Locally Advanced Solid Tumor
A Study to Investigate Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination With Pembrolizumab and/or TransCon TLR7/8 Agonist or Other Anticancer Therapies in Adult Participants With Locally Advanced or Metastatic Solid Tumor Malignancies
TransCon IL-2 β/γ is an investigational drug being developed for treatment of locally advanced or metastatic solid tumors. This is a first-in-human, open-label, Phase 1/2, dose escalation and dose expansion study of TransCon IL-2…
- Conditions
- Advanced Solid Tumor, Locally Advanced Solid Tumor, Metastatic Solid Tumor, Platinum-resistant Ovarian Cancer
- Trial name
- IL Believe (NCT05081609)
- Testing
- TransCon IL-2 β/γ, Pembrolizumab, Chemotherapy drug
- Where
- 68 sites in United States, Australia and 8 more
- Volunteers
- 320 people
- Sponsor
- Ascendis Pharma Oncology Division A/S
Malignant Melanoma
Neoadjuvant L19IL2/L19TNF- Pivotal Study
Phase III, open-label, randomized, controlled multi-center study of the efficacy of L19IL2/L19TNF neoadjuvant intratumoral treatment in Stage III B/C melanoma patients.
- Trial name
- Pivotal (NCT02938299)
- Testing
- L19IL2 + L19TNF, Surgery
- Where
- 22 sites in France, Germany and 2 more
- Volunteers
- 214 people
- Sponsor
- Philogen S.p.A.
Melanoma
Real-world Outcomes Among Patients With Melanoma Treated With Neoadjuvant Nivolumab+Relatlimab or Nivolumab+Ipilimumab
The purpose of this study is to understand the characteristics of adults diagnosed with with clinically palpable stage III resectable melanoma, the associated treatment patterns for their disease, and outcomes associated with the…
- Trial name
- NCT07091695
- Testing
- Nivolumab + relatlimab, Nivolumab + ipilimumab
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Bristol-Myers Squibb
Melanoma, Squamous Cell Carcinoma of Head and Neck
Phase II Trial of Neoadjuvant and Adjuvant IO102-IO103 and Pembrolizumab KEYTRUDA® in Patients With Resectable Tumors
This is a multicenter, multi-arm trial evaluating anti-tumor activity, safety, and immune infiltration of IO102-IO103 in combination with pembrolizumab KEYTRUDA® as neoadjuvant and post-surgery treatment.
- Trial name
- NCT05280314
- Testing
- IO102-IO103, Pembrolizumab KEYTRUDA®
- Where
- 15 sites in United States, Australia and 4 more
- Volunteers
- 60 people
- Sponsor
- IO Biotech
Melanoma
Substudy 02C: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With Stage III Melanoma Who Are Candidates for Neoadjuvant Therapy (MK-3475-02C/KEYMAKER-U02)
Substudy 02C is part of a larger research study that is testing experimental treatments for melanoma, a type of skin cancer. The larger study is the umbrella study.
- Trial name
- NCT04303169
- Testing
- Pembrolizumab, Vibostolimab, Gebasaxturev
- Where
- 29 sites in United States, Australia and 4 more
- Volunteers
- 146 people
- Sponsor
- Merck Sharp & Dohme LLC
Melanoma Stage IIIB, Melanoma Stage IIIC
Efficacy of Daromun Neoadjuvant Intratumoral Treatment in Clinical Stage IIIB/C/D Melanoma Patients
The trial aims to evaluate the efficacy of Daromun neoadjuvant treatment followed by surgery and adjuvant therapy to improve in a statistically significant manner the recurrence-free survival (RFS) of Stage IIIB/C/D melanoma…
- Conditions
- Melanoma Stage IIIB, Melanoma Stage IIIC, Melanoma Stage IIID
- Trial name
- NeoDREAM (NCT03567889)
- Testing
- Daromun, Surgery, Adjuvant therapy
- Where
- 37 sites in United States, Spain and 1 more
- Volunteers
- 186 people
- Sponsor
- Philogen S.p.A.
Squamous Cell Carcinoma of the Skin, Malignant Melanoma of Skin
Intratumoral PH-762 for Cutaneous Carcinoma
The goal of this clinical trial is to evaluate the safety and tolerability of intratumoral injections of PH-762 in squamous cell carcinoma, melanoma, or Merkel cell carcinomas of the skin, to understand what the body does to the…
- Conditions
- Squamous Cell Carcinoma of the Skin, Malignant Melanoma of Skin, Merkel Cell Carcinoma of Skin
- Trial name
- NCT06014086
- Testing
- PH-762
- Where
- 5 sites in United States
- Volunteers
- 22 people
- Sponsor
- Phio Pharmaceuticals Inc.