A Phase 2 interventional study of Pembrolizumab and Ipilimumab plus nivolumab in Melanoma (Skin Cancer), Melanoma Stage Stage IIIB and Melanoma Stage M1, sponsored by UNC Lineberger Comprehensive Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by UNC Lineberger Comprehensive Cancer Center · Phase 2, Interventional, and Treatment
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Among 87 studies testing pembrolizumab in Melanoma — 20 open to participants now, 41 under way, 7 of them phase 3. pembrolizumab · Melanoma.
Among the 87 studies testing pembrolizumab in Melanoma, this one is the 43rd largest by planned enrollment, is one of 5 that started in 2026, is one of 49 in phase 2, reaches primary completion later than 33 of the 40 other live ones, and was the 85th registered.
3,372 studies on the registry are indexed under Melanoma; 580 are open to participants now.
Browse Melanoma studies →20 of the 87 studies testing pembrolizumab in Melanoma are open now, in 12 countries. Recruiting first, the newest first:
Swiss Cancer Institute · Sites in Switzerland
Ages 18+
Vastra Gotaland Region · Sites in Sweden
Ages 18+
Diwakar Davar · Sites in United States
Ages 18+
EuroCityClinic LLC · Sites in Russia
Ages 18+
Universitair Ziekenhuis Brussel · Sites in Belgium
Ages 18+
By country, each count listing its studies:
pembrolizumab: first FDA approval 2014 (KEYTRUDA), first EMA approval 2015. What it is approved for, and how studies give it, is on its page →
Of the 468 Melanoma studies recruiting now, 381 (81%) set no upper age limit and 49 (10%) stop at 75 or younger; 47 take children under 18; 29 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
On this site’s reading of the record, pembrolizumab is the treatment under test here. Read study by study →
87 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 26 · Phase 2 58 · Phase 3 10 · Phase 4 1
First in 2011; this study’s year is marked. 5 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 55 is above the median of 40 across 2,650 interventional studies indexed under Melanoma.
Median enrollment 53 across the 87 interventional studies. Of the 38 that completed or were terminated, 24 (63%) have results posted.
This tab as a report to print or save as PDF → With an account.
24 of 87 have an industry lead sponsor. The 10 most frequent:
UNC Lineberger Comprehensive Cancer Center is the lead sponsor of 429 studies on the registry; 97 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 26 (79%) have results posted.
UNC Lineberger Comprehensive Cancer Center has 7 studies filed under Melanoma — fewer than ten, so there is no comparison to draw.
6 of the studies testing pembrolizumab in Melanoma that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03313206Gustave Roussy, Cancer Campus, Grand ParisNeoadjuvant Treatment Associated With Maintenance Therapy by Anti-PD1 Immunotherapy in Patients With Resectable Head and Neck Mucosal Melanoma | 2027-01 |
| NCT07376317Instituto do Cancer do Estado de São PauloOptimization of Immunotherapy Treatment for Advanced Melanoma in the Context of the Public Brazilian Health System (OTIMAS) | 2027-01-30 |
| NCT04462406ECOG-ACRIN Cancer Research GroupUsing Biomarkers to Help Guide Safe Immunotherapy Discontinuation in Patients With Unresectable Stage IIIB-IV Melanoma, The PET-Stop Trial | 2027-01-31 |
| NCT07422779Institute of Oncology LjubljanaImmunotherapy Efficacy and PD-L1 as a Predictive Biomarker in Metastatic Melanoma in Slovenia | 2027-03-31 |
| NCT06906822Grupo Español Multidisciplinar de MelanomaPLUG-IN: Pembrolizumab Combined With Enfortumab Vedotin for Advanced Melanoma Patients | 2027-06 |
Add all 6 to your calendar (.ics) → With an account.
Among the 87 studies testing pembrolizumab in Melanoma, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study evaluates the impact of neoadjuvant Programmed cell death Protein 1 (PD-1)-based treatment regimens in patients with resectable stage IIIB-M1a cutaneous or unknown primary melanoma at high risk of relapse without adjuvant therapy after definitive lymphadenectomy and irrespective of pathologic response outcome on the 2-year overall survival (OS). It was hypothesized that neoadjuvant PD1 inhibitor-based treatment without adjuvant treatment does not significantly (non-inferior) impact OS in this study patient population. Patients will be randomized to either two infusions of pembrolizumab or one infusion of ipilimumab plus nivolumab followed by a single infusion of nivolumab. Patients will undergo follow-up and restaging scans to assess event-free survival at 12 months and OS at 24 months after the first neoadjuvant treatment infusion.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Versions of RECIST adapted to particular cases. iRECIST is for immunotherapy, where a tumour can look bigger for a while before it shrinks, so growth has to be confirmed on a later scan. mRECIST usually means the version for liver cancer (hepatocellular carcinoma), which measures only the part of a tumour that still has a blood supply.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
iRECIST and mRECIST
Versions of RECIST adapted to particular cases. iRECIST is for immunotherapy, where a tumour can look bigger for a while before it shrinks, so growth has to be confirmed on a later scan. mRECIST usually means the version for liver cancer (hepatocellular carcinoma), which measures only the part of a tumour that still has a blood supply.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive pembrolizumab 200 mg IV, every 3 weeks, times 2 infusions followed by lymph node dissection, followed by no adjuvant treatment.
Drug: Pembrolizumab
Participants receive ipilimumab (3 mg/kg) plus nivolumab (1 mg/kg) x one infusion, followed by a single infusion of nivolumab 240 mg IV 3 weeks later, followed by lymph node dissection, followed by no adjuvant treatment
Drug: Ipilimumab plus nivolumab
Pembrolizumab 200 mg IV, every 3 weeks
Single infusion of concurrent ipilimumab (3 mg/kg) plus nivolumab (1 mg/kg) followed by a single infusion of nivolumab 240 mg IV 3 weeks later
This study also gives Nivolumab, Ipilimumab. No intervention listed here names it: that was found by reading the record.
Overall survival
The overall survival (OS) rate will be defined from the initiation of study treatments for the combined patient cohorts (cohort A and cohort B).
Time frame: 2-year
Event - Free Survival (EFS)
The Event - Free Survival (EFS) rate will be defined from the initiation of study treatments for the combined patient cohorts (cohort A and cohort B).
Time frame: 1-year
Major pathologic response (MPR) rate
The MPR rate for each of the two study treatment cohorts (cohort A and cohort B) will be defined using established pathologic response criteria. Pathologic response will be assessed by determining the percentage of residual viable tumor in the resected specimen. Major pathologic response is defined as ≤10% residual viable tumor, and pathologic complete response is defined as the absence of viable tumor cells.
Time frame: Up to 12 weeks
Treatment Related Adverse Events (TRAEs)
TRAEs are defined as adverse events assessed by the investigator as related to study treatment, Grade 3 or higher grades. The incidence of TRAEs will be determined separately for each of the two cohorts and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 6.0. CTCAE classifies severity as follows: Grade 1 - asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 - minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL). Grade 3 - severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 - life-threatening consequences; urgent intervention indicated. Grade 5 - death related to the adverse event.
Time frame: Up to 12 weeks
Started Aug 2026 (actual). Primary completion is estimated for Mar 2029, 31 months after the start.
Of 278 non-industry phase 2 interventional studies under Melanoma, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 94. This study's planned 31 months is below that.
Counting every sponsor, half of 384 studies reached it within 53 months; a quarter within 32 and three quarters within 90.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drugs tested here: Pembrolizumab · Nivolumab · Ipilimumab
UNC Lineberger Comprehensive Cancer Center →