Melanoma Stage IIIPhase 2NCT04139902
Neoadjuvant PD-1 Inhibitor Dostarlimab (TSR-042) vs. Combination of Tim-3 Inhibitor Cobolimab (TSR-022) and PD-1 Inhibitor Dostarlimab (TSR-042) in Melanoma
A Phase 2 study testing Dostarlimab (TSR-042) (singly) and Dostarlimab (TSR-042) and TSR-022 (combination) in people with Melanoma Stage III and Melanoma Stage IV, run by Diwakar Davar at 5 sites in United States.
Trial summary
The purpose of this study is to test the effects of anti-PI-1 inhibitor (TSR-042) or anti-PD-1/anti-TIM-3 combination (TSR-042 / TSR-022) in patients with operable melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma Stage III, Melanoma Stage IV
- What is being tested?
- Dostarlimab (TSR-042) (singly) and Dostarlimab (TSR-042) and TSR-022 (combination)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 5 sitesUnited States
- Study dates
- 12 Jun 2020to 15 Dec 2029
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- written informed consent for the study
- ≥ 18 years of age
- histologically or cytologically confirmed diagnosis of cutaneous or unknown primary melanoma (excluding uveal/choroidal and mucosal melanoma; although acral melanoma is included) belonging to one of the following AJCC 8th edition TNM stages:
- Tx or T1-4 AND
- N1b, or N1c, or N2b, or N2c, or N3b, or N3c AND/OR
- M1a or M1b
Show all 15Show fewer
- Patients are eligible for this trial either at presentation for primary melanoma with concurrent regional nodal and/or in-transit metastasis and/or oligometastasis; AND/OR at the time of clinical detected nodal and/or in-transit and/or oligometastatic recurrence; and may belong to any of the following groups:
- Primary melanoma with clinically apparent regional lymph node metastases; Clinically detected recurrent melanoma at the proximal regional lymph node(s) basin; Clinically detected primary melanoma involving multiple regional nodal groups; Clinical detected nodal melanoma (if single site) arising from an unknown primary; In-transit and/or satellite metastases with or without regional lymph node involvement; Distant skin and/or in-transit and/or satellite metastases with or without regional lymph node involvement; Oligometastatic lung disease with or without regional lymph node involved permitted if deemed resectable at baseline NOTE: Determination of resectability must be made at baseline to be eligible for this neoadjuvant study.
- measurable disease based on RECIST 1.1
- must provide tumor tissue from a newly obtained core, punch, incisional or excisional tumor biopsy
- 0 or 1 on the ECOG Performance Scale
- Demonstrate adequate organ function on screening labs obtained within 14 days of registration
- negative serum pregnancy test (females of childbearing potential)
- females of non-childbearing potential must be ≥45 years of age and has not had menses for >1 year; if amenorrhoeic for <2 years without history of a hysterectomy and oophorectomy must have an FSH value in the postmenopausal range; post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation (documented hysterectomy or oophorectomy)
- male subjects should agree to use an adequate method of contraception
Who cannot join
- Patients with uveal and/or mucosal melanoma histology are excluded (Patients with melanoma of unknown histology are permitted to enroll after discussion with Principal Investigator)
- Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment.
- Is receiving systemic immunosuppression with either corticosteroids (>10mg daily prednisone equivalent) or other immunosuppressive medications) for active autoimmune disease: history of active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids (>10mg daily prednisone or equivalent) or systemic immunosuppressive agents
- ≥ CTCAE grade 3 immune-related AE (irAE) experienced with prior immunotherapy (except, non-clinically significant lab abnormalities (elevations in lipase, amylase not associated with clinically significant disease etc.) even if ≥ CTCAE grade 3 may enroll if resolved at this time, or, development of autoimmune disorders of Grade ≤ 3 may enroll if the disorder has resolved to Grade ≤ 1)
- received prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent (except ≤ Grade 2 neuropathy)
- autoimmune disorders of Grade 4 while on prior immunotherapy
Show all 19Show fewer
- active (i.e., symptomatic or growing) central nervous system (CNS) and/or leptomeningeal metastases (CNS lesions that are treated and deemed stable (repeat imaging study done at least 2 weeks prior to first dose of study treatment) are NOT permitted to enroll even if other inclusion criteria are met and patients are neurologically asymptomatic)
- known additional malignancy that is progressing or requires active treatment (except, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy)
- invasive cancer diagnosed and treated less than 2 years prior to current presentation (other indolent malignancies that are not progressing and/or deemed to require active therapy are not exclusionary)
- evidence of interstitial lung disease or active, non-infectious pneumonitis
- active infection requiring systemic therapy
- history or current evidence of any condition, therapy, or laboratory abnormality determined to be significant, in the opinion of the treating investigator
- known psychiatric or substance abuse disorders that would interfere with study compliance
- is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial
- had a live vaccine within 30 days of initiating protocol therapy
- received prior therapy with an IDO inhibitor, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 and/or combination (including nivolumab, pembrolizumab or ipilimumab/nivolumab). Prior treatment with ipilimumab or interferon alfa is allowed.
- history of allergic or hypersensitivity reaction to components or excipients of Dostarlimab (TSR-042) and TSR-022, interferon alfa or ipilimumab
- known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
- known history of or screening test that is positive for hepatitis B virus (HBV; eg, HBsAg reactive or HBV DNA detected) or hepatitis C virus (HCV; HCV antibody positive and/or HCV RNA quantitative is detected). Hepatitis C antibody - positive subjects who received and completed treatment for hepatitis C that was intended to eradicate the virus may participate if hepatitis C RNA levels are undetectable. Hepatitis B positive subjects who received and completed treatment for hepatitis B that was intended to eradicate the virus may participate if hepatitis B DNA levels are undetectable.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
UPMC Hillman Cancer Center Washington
Washington, Pennsylvania, 15301
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
About this study
Official title: PHASE II NEOADJUVANT STUDY OF PD-1 INHIBITOR DOSTARLIMAB (TSR-042) VS. COMBINATION OF TIM-3 INHIBITOR COBOLIMAB (TSR-022) AND PD-1 INHIBITOR DOSTARLIMAB (TSR-042) IN RESECTABLE STAGE III OR OLIGOMETASTATIC STAGE IV MELANOMA (NEO-MEL-T)
The purpose of this study is to test the effects of anti-PI-1 inhibitor (TSR-042) or anti-PD-1/anti-TIM-3 combination (TSR-042 / TSR-022) in patients with operable melanoma.
Read the detailed description
This is a randomized phase II neoadjuvant study comparing neoadjuvant therapy with PD-1 inhibitor Dostarlimab (TSR-042) to the PD-1/TIM-3 inhibitor combination Dostarlimab (TSR-042)/TSR-022 in patients with resectable regionally advanced or oligometastatic melanoma.
Patients with stage III B/C/D or oligometastatic stage IV A melanoma with lymph node (LN) and/or in-transit and/or oligometastatic disease who have yet to undergo definitive surgery are eligible to enroll.
Suitable patients will be identified pre-operatively. Patients will undergo screening evaluation consisting of systemic/CNS staging scans, tumor biopsy, blood studies to confirm suitability. Subjects will receive neoadjuvant therapy (Dostarlimab (TSR-042) or Dostarlimab (TSR-042)/TSR-022 combination for 6 weeks prior to planned surgery (pre-operative phase). Surgery will occur 1-4 weeks after completion of pre-operative therapy. After recovery from surgery subjects will receive Dostarlimab (TSR-042) (Post-Operative phase) for approximately 48 weeks; for a total of 54 weeks of study drug(s) administration in total.
In September of 2026, the outcome measures were updated to align with the current approved protocol and statistical analysis plan.
- Conditions
- Melanoma Stage III, Melanoma Stage IV
- Being tested
- Dostarlimab (TSR-042) (singly), Dostarlimab (TSR-042) and TSR-022 (combination)
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dostarlimab (TSR-042) (singly)Drug
Also called Dostarlimab
If patients are randomized to Dostarlimab (TSR-042) alone, during the Pre-operative Phase, 500mg will be administered through an IV over 30 minutes, on Cycle 1 Day 1, and then again on Cycle 2 Day 1.
Surgery will occur 1-4 weeks after completion of the pre-operative phase.
During the Post-operative phase, Dostarlimab (TSR-042) 500mg will be administered through an IV over 30 minutes for 4 cycles every 3 weeks (Cycles 3-4), and then 1000mg will be administered through an IV over 30 minutes every 6 weeks (Cycles 5-10) for approximately 48 weeks.
Dostarlimab (TSR-042) and TSR-022 (combination)Drug
If patients are randomized to the combination, Dostarlimab (TSR-042) and TSR-022, during the Pre-operative Phase, Dostarlimab (TSR-042) 500mg and TSR-022 300mg will be administered through an IV over 30 minutes on Cycle 1 Day 1 and then again on Cycle 2 Day 1.
Surgery will occur 1-4 weeks after completion of the pre-operative phase.
During the Post-operative Phase, Dostarlimab (TSR-042) 500mg will be administered through an IV over 30 minutes for 4 cycles every 3 weeks (Cycles 3-4) and then 1000mg will be administered through an IV over 30 minutes every 6 weeks for 6 doses (Cycles 5-10) for approximately 48 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Dostarlimab (TSR-042) (singly) | Experimental | Pre-Operative Phase:
Dostarlimab (TSR-042) 500mg will be administered through an IV over 30 minutes, on Cycle 1 Day 1, and then again on Cycle 2 Day 1.
Post-Operative Phase:
Dostarlimab (TSR-042) 500mg will be administered through an IV over 30 minutes for 4 doses every 3 weeks (Cycles 3-4) and then 1000mg will be administered through an IV over 30 minutes every 6 weeks for 6 doses (Cycles 5-10) for approximately 48 weeks. Receives: Drug: Dostarlimab (TSR-042) (singly) |
| Dostarlimab (TSR-042) and Cobolimab TSR-022 (combination) | Experimental | Pre-Operative Phase:
Dostarlimab (TSR-042) 500mg and Cobolimab TSR-022 300mg will be administered through an IV over 30 minutes, on Cycle 1 Day 1 and then again on Cycle 2 Day 1.
Post-Operative Phase:
Dostarlimab (TSR-042) will be administered through an IV over 30 minutes for 4 doses every 3 weeks (Cycles 3-4), and then 1000mg will be administered through an IV over 30 minutes every 6 weeks for 6 doses (Cycles 5-10) for approximately 48 weeks. TSR-022 will not be administered. Receives: Drug: Dostarlimab (TSR-042) and TSR-022 (combination) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Pathologic Response (MPR)
Percentage of patients with an RVT (residual volume of viable tumor) of ≤10% remaining in post-therapy specimen using immunotherapy-specific pathologic assessment of neoadjuvant treated melanoma specimens.
Measured: Time of Surgery (planned between 6-10 weeks from start of treatment)
Secondary outcomes (5)
Number of Participants Experiencing Adverse Events Attributed to Treatment
Number of participants experiencing adverse events (per CTCAE v5.0) that are possibly, probably or definitely related to study treatment, will be tabulated by category, grade and relatedness. AEs will be collected for 30 days after the last dose of study therapy, but any SAEs occurring up to 90 days after the last dose of study therapy will additionally be recorded.
Measured: Up to 90 days after last dose of study therapy
Frequency of Delays in Surgery
Number of participants experiencing delays in their surgical procedures. A delay in surgery is defined as a surgery that occurs more than 6 weeks after completion of pre-operative therapy for reasons related to toxicity or progression.
Measured: Time of Surgery (planned between 6-10 weeks from start of treatment)
Frequency of Cancellations of Surgery
Number of participants experiencing a cancellation of their surgical procedure.
Measured: Time of Surgery (planned between 6-10 weeks from start of treatment)
Relapse-free Survival
The length of time from initiation of study drug(s) until melanoma relapse (disease progression) as defined by RECIST v1.1, or death. Progressive Disease (PD): ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.
Measured: Up to 5 years from initiation of study treatment
Overall Survival (OS)
The length of time from initiation of study drug(s) that patients remain alive.
Measured: Up to 5 years from initiation of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start12 Jun 2020
- Primary completion29 Sep 2025
- Study completion15 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Melanoma Stage IIIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diwakar Davar
- Sponsor type
- University, hospital or other
- Collaborators
- Tesaro, Inc.
- Responsible party
- Sponsor-investigator, Diwakar Davar, University of Pittsburgh
- Investigators
- Diwakar Davar, MD, Principal investigator, UPMC Hillman Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04139902
- Sponsor's protocol ID
- 19-047
- Status last verified
- Sep 2026
- First submitted
- 23 Oct 2019
- Last updated
- 20 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gorry C, McCullagh L, O'Donnell H, Barrett S, Schmitz S, Barry M, Curtin K, Beausang E, Barry R, Coyne I. Neoadjuvant treatment for stage III and IV cutaneous melanoma. Cochrane Database Syst Rev. 2023 Jan 17;1(1):CD012974. doi: 10.1002/14651858.CD012974.pub2.
PubMed 36648215
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHASE II NEOADJUVANT STUDY OF PD-1 INHIBITOR DOSTARLIMAB (TSR-042) VS. COMBINATION OF TIM-3 INHIBITOR COBOLIMAB (TSR-022) AND PD-1 INHIBITOR DOSTARLIMAB (TSR-042) IN RESECTABLE STAGE III OR OLIGOMETASTATIC STAGE IV MELANOMA (NEO-MEL-T)
- ClinicalTrials.gov ID
- NCT04139902
- Acronym / sponsor ID
- 19-047
- Conditions
- Melanoma Stage III, Melanoma Stage IV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Diwakar DavarUniversity, hospital or other
- Collaborators
- Tesaro, Inc.
- Study start
- 12 Jun 2020 (actual)
- Primary completion
- 29 Sep 2025 (actual)
- Study completion
- 15 Dec 2029 (estimated)
- First posted
- 25 Oct 2019 (actual)
- Results
- Posted 20 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the effects of anti-PI-1 inhibitor (TSR-042) or anti-PD-1/anti-TIM-3 combination (TSR-042 / TSR-022) in patients with operable melanoma.
Detailed description
This is a randomized phase II neoadjuvant study comparing neoadjuvant therapy with PD-1 inhibitor Dostarlimab (TSR-042) to the PD-1/TIM-3 inhibitor combination Dostarlimab (TSR-042)/TSR-022 in patients with resectable regionally advanced or oligometastatic melanoma.
Patients with stage III B/C/D or oligometastatic stage IV A melanoma with lymph node (LN) and/or in-transit and/or oligometastatic disease who have yet to undergo definitive surgery are eligible to enroll.
Suitable patients will be identified pre-operatively. Patients will undergo screening evaluation consisting of systemic/CNS staging scans, tumor biopsy, blood studies to confirm suitability. Subjects will receive neoadjuvant therapy (Dostarlimab (TSR-042) or Dostarlimab (TSR-042)/TSR-022 combination for 6 weeks prior to planned surgery (pre-operative phase). Surgery will occur 1-4 weeks after completion of pre-operative therapy. After recovery from surgery subjects will receive Dostarlimab (TSR-042) (Post-Operative phase) for approximately 48 weeks; for a total of 54 weeks of study drug(s) administration in total.
In September of 2026, the outcome measures were updated to align with the current approved protocol and statistical analysis plan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dostarlimab (TSR-042) (singly) | Experimental | Drug: Dostarlimab (TSR-042) (singly)Pre-Operative Phase: Dostarlimab (TSR-042) 500mg will be administered through an IV over 30 minutes, on Cycle 1 Day 1, and then again on Cycle 2 Day 1. Post-Operative Phase: Dostarlimab (TSR-042) 500mg will be administered through an IV over 30 minutes for 4 doses every 3 weeks (Cycles 3-4) and then 1000mg will be administered through an IV over 30 minutes every 6 weeks for 6 doses (Cycles 5-10) for approximately 48 weeks. |
| Dostarlimab (TSR-042) and Cobolimab TSR-022 (combination) | Experimental | Drug: Dostarlimab (TSR-042) and TSR-022 (combination)Pre-Operative Phase: Dostarlimab (TSR-042) 500mg and Cobolimab TSR-022 300mg will be administered through an IV over 30 minutes, on Cycle 1 Day 1 and then again on Cycle 2 Day 1. Post-Operative Phase: Dostarlimab (TSR-042) will be administered through an IV over 30 minutes for 4 doses every 3 weeks (Cycles 3-4), and then 1000mg will be administered through an IV over 30 minutes every 6 weeks for 6 doses (Cycles 5-10) for approximately 48 weeks. TSR-022 will not be administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- written informed consent for the study
- ≥ 18 years of age
- histologically or cytologically confirmed diagnosis of cutaneous or unknown primary melanoma (excluding uveal/choroidal and mucosal melanoma; although acral melanoma is included) belonging to one of the following AJCC 8th edition TNM stages:
- Patients are eligible for this trial either at presentation for primary melanoma with concurrent regional nodal and/or in-transit metastasis and/or oligometastasis; AND/OR at the time of clinical detected nodal and/or in-transit and/or oligometastatic recurrence; and may belong to any of the following groups:
- Primary melanoma with clinically apparent regional lymph node metastases; Clinically detected recurrent melanoma at the proximal regional lymph node(s) basin; Clinically detected primary melanoma involving multiple regional nodal groups; Clinical detected nodal melanoma (if single site) arising from an unknown primary; In-transit and/or satellite metastases with or without regional lymph node involvement; Distant skin and/or in-transit and/or satellite metastases with or without regional lymph node involvement; Oligometastatic lung disease with or without regional lymph node involved permitted if deemed resectable at baseline NOTE: Determination of resectability must be made at baseline to be eligible for this neoadjuvant study.
Key exclusion criteria (19 listed)
- Patients with uveal and/or mucosal melanoma histology are excluded (Patients with melanoma of unknown histology are permitted to enroll after discussion with Principal Investigator)
- Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment.
- Is receiving systemic immunosuppression with either corticosteroids (>10mg daily prednisone equivalent) or other immunosuppressive medications) for active autoimmune disease: history of active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids (>10mg daily prednisone or equivalent) or systemic immunosuppressive agents
- ≥ CTCAE grade 3 immune-related AE (irAE) experienced with prior immunotherapy (except, non-clinically significant lab abnormalities (elevations in lipase, amylase not associated with clinically significant disease etc.) even if ≥ CTCAE grade 3 may enroll if resolved at this time, or, development of autoimmune disorders of Grade ≤ 3 may enroll if the disorder has resolved to Grade ≤ 1)
- received prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent (except ≤ Grade 2 neuropathy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dostarlimab (TSR-042) (singly)Also: DostarlimabIf patients are randomized to Dostarlimab (TSR-042) alone, during the Pre-operative Phase, 500mg will be administered through an IV over 30 minutes, on Cycle 1 Day 1, and then again on Cycle 2 Day 1. Surgery will occur 1-4 weeks after completion of the pre-operative phase. During the Post-operative phase, Dostarlimab (TSR-042) 500mg will be administered through an IV over 30 minutes for 4 cycles every 3 weeks (Cycles 3-4), and then 1000mg will be administered through an IV over 30 minutes every 6 weeks (Cycles 5-10) for approximately 48 weeks. | Drug | Dostarlimab (TSR-042) (singly) |
| Dostarlimab (TSR-042) and TSR-022 (combination)If patients are randomized to the combination, Dostarlimab (TSR-042) and TSR-022, during the Pre-operative Phase, Dostarlimab (TSR-042) 500mg and TSR-022 300mg will be administered through an IV over 30 minutes on Cycle 1 Day 1 and then again on Cycle 2 Day 1. Surgery will occur 1-4 weeks after completion of the pre-operative phase. During the Post-operative Phase, Dostarlimab (TSR-042) 500mg will be administered through an IV over 30 minutes for 4 cycles every 3 weeks (Cycles 3-4) and then 1000mg will be administered through an IV over 30 minutes every 6 weeks for 6 doses (Cycles 5-10) for approximately 48 weeks. | Drug | Dostarlimab (TSR-042) and Cobolimab TSR-022 (combination) |
Primary outcome
Major Pathologic Response (MPR)
Time frame: Time of Surgery (planned between 6-10 weeks from start of treatment)
Percentage of patients with an RVT (residual volume of viable tumor) of ≤10% remaining in post-therapy specimen using immunotherapy-specific pathologic assessment of neoadjuvant treated melanoma specimens.
5 secondary outcomes
Number of Participants Experiencing Adverse Events Attributed to Treatment
Time frame: Up to 90 days after last dose of study therapy
Frequency of Delays in Surgery
Time frame: Time of Surgery (planned between 6-10 weeks from start of treatment)
Frequency of Cancellations of Surgery
Time frame: Time of Surgery (planned between 6-10 weeks from start of treatment)
Relapse-free Survival
Time frame: Up to 5 years from initiation of study treatment
Overall Survival (OS)
Time frame: Up to 5 years from initiation of study treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36648215Gorry C, McCullagh L, O'Donnell H, Barrett S, Schmitz S, Barry M, Curtin K, Beausang E, Barry R, Coyne I. Neoadjuvant treatment for stage III and IV cutaneous melanoma. Cochrane Database Syst Rev. 2023 Jan 17;1(1):CD012974. doi: 10.1002/14651858.CD012974.pub2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diwakar Davar, MD principal investigator
UPMC Hillman Cancer Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dostarlimab (TSR-042) (singly) and Dostarlimab (TSR-042) and TSR-022 (combination) in people with Melanoma Stage III and Melanoma Stage IV, run by Diwakar Davar at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Pathologic Response (MPR) (time frame: Time of Surgery (planned between 6-10 weeks from start of treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04139902, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.