MelanomaPhase 2NCT02621021
A Phase 2 Trial for Metastatic Melanoma Using Adoptive Cell Therapy With Tumor Infiltrating Lymphocytes Plus IL-2 Either Alone or Following the Administration of Pembrolizumab
A Phase 2 study testing young TIL, Pembrolizumab and Aldesleukin in people with Melanoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Cell therapy is an experimental cancer therapy. It takes young tumor infiltrating lymphocytes (Young TIL) cells from a person s tumors and grows them in a lab. Then they are returned to the person. Researchers think adding the drug pembrolizumab might make the therapy more effective. Read more about this study
- Who is it for?
- Ages 18 to 72 years
- Conditions the study is for
- Melanoma
- What is being tested?
- young TIL, Pembrolizumab and Aldesleukin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2015to 16 Jun 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 to 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Individuals of child-bearing potential who are pregnant or nursing because of the potentially dangerous effects of the treatment on the fetus or infant.
- Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).
- Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities.)
- Active systemic infections requiring anti-infective treatment, coagulation disorders or any other active major medical illnesses.
- History of major organ autoimmune disease
- Concurrent systemic steroid therapy.
Show all 12Show fewer
- History of severe immediate hypersensitivity reaction to any of the agents used in this study.
- Grade 3 or 4 major organ Immune-related Adverse Events (IRAEs) clinically attributed to anti PD-1/PD-L1 monotherapy. Previously screened participants that experience these IRAEs after resection for creation of TIL are excluded from Arm 2, but may be eligible for assignment to Arm 3. NOTE: For the purposes of this protocol, thyroid is not considered a major organ.
- History of coronary revascularization or ischemic symptoms.
- For select patients with a clinical history prompting cardiac evaluation: last LVEF less than or equal to 45%
- For select patients with a clinical history prompting pulmonary evaluation: known FEV1 less than or equal to 50%.
- Patients who are receiving any other investigational agents.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: A Phase II Trial for Metastatic Melanoma Using Adoptive Cell Therapy With Tumor-Infiltrating Lymphocytes Plus IL-2 Either Alone or Following the Administration of Pembrolizumab
Background:
Cell therapy is an experimental cancer therapy. It takes young tumor infiltrating lymphocytes (Young TIL) cells from a person s tumors and grows them in a lab. Then they are returned to the person. Researchers think adding the drug pembrolizumab might make the therapy more effective.
Read more
Objective:
To test if adding pembrolizumab to cell therapy is safe and effective to shrink melanoma tumors.
Eligibility:
People ages 18-72 years with metastatic melanoma OF THE SKIN
Design:
Participants will be screened with:
Physical exam
CT, MRI, or PET scans
X-rays
Heart and lung function tests if indicated
Blood and urine tests
Before treatment, participants will have:
A piece of tumor taken from a biopsy or during surgery in order to grow TIL cells
Leukapheresis: Blood flows through a needle in one arm and into a machine that removes white blood cells.
The rest of the blood returns through a needle in the other arm.
An IV catheter placed in the chest for getting TIL cells, aldesleukin, and pembrolizumab (if assigned)
Participants will stay in the hospital for treatment. This includes:
Daily chemotherapy for 1 week
For some participants, pembrolizumab infusion 1 day after chemotherapy
TIL cell infusion 2-4 days after chemotherapy, then aldesleukin infusion every 8 hours for up to 12 doses
Filgrastim injections to help restore your blood counts
Recovery for 1-3 weeks
After treatment, participants will:
Take an antibiotic and an antiviral for at least 6 months, as applicable
If assigned, have pembrolizumab treatment every 3 weeks for 3 more doses. They may have another round.
Have 2-day follow-up visits every 1-3 months for 1 year and then every 6 months
Read the detailed description
Background:
- Adoptive cell therapy (ACT) using autologous tumor infiltrating lymphocytes (TIL) can mediate the regression of bulky metastatic melanoma when administered along with high-dose aldesleukin (IL-2) following a non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine.
- Pembrolizumab, a monoclonal antibody that binds to PD-1 and blocks the PD-1/PD-L1 axis, facilitates the activity of anti-tumor lymphocytes in the tumor micro environment. Pembrolizumab administration can result in objective tumor responses in patients with metastatic melanoma and is approved for use by the FDA for the treatment of these patients.
- Administered TIL express low levels of PD-1, though PD-1 can be re-expressed on TIL in vivo following TIL administration.
- In pre-clinical models, the administration of an anti-PD1 antibody enhances the anti-tumor activity of transferred T-cells.
Objectives:
Primary Objectives:
-Revised Study Design: Determine the objective response rate with the addition of pembrolizumab to the standard non-myeloablative conditioning regimen, TIL, and high-dose IL-2 in patients with metastatic melanoma who have received prior anti-PD-1/PD-L1 therapy (Cohorts 1 and 3).
Original Study Design (retained for historical purposes):
- Determine in a prospective randomized trial whether the addition of pembrolizumab to the standard non-myeloablative conditioning regimen, TIL, and high-dose IL-2 can improve complete response rates in patients with metastatic melanoma who have received prior anti-PD-1/PD-L1 therapy (Cohort 1).
- Determine the complete response rate to the standard non-myeloablative conditioning regimen, TIL, and high-dose IL-2 in combination with pembrolizumab in patients with metastatic melanoma who have not received prior anti-PD-1/PD-L1 therapy (Cohort 2).
Eligibility:
Patients must be/have:
- Age greater than or equal to 18 years and less than or equal to 72 years
- Evaluable metastatic melanoma
- Metastatic melanoma lesion suitable for surgical resection for the preparation of TIL
- No allergies or hypersensitivity to high-dose aldesleukin administration
- No concurrent major medical illnesses or any form of immunodeficiency
Design:
- Patients with metastatic melanoma will have lesions resected for TIL.
- Patients will be assigned to one of three cohorts: (1) patients who are refractory to prior anti-PD-1/PD-L1 therapy (randomized); (2) patients who have not received prior anti-PD-1/PD-L1 therapy; and (3) patients who are refractory to anti PD-1/PD-L1 (nonrandomized). Note: Cohorts 1 and 2 were closed upon the addition of Cohort 3.
- After TIL growth is established:
- Original Study Design:
Patients assigned to Cohort 1 will be randomized to either receive or not receive pembrolizumab in combination with the standard non-myeloablative conditioning regimen, TIL, and high-dose IL-2. All patients assigned to Cohort 2 will receive the standard non-myeloablative conditioning regimen, TIL, and high-dose IL-2 in combination with pembrolizumab.
--Revised Study Design: Patients assigned to Cohort 3 without contraindications to pembrolizumab, will be assigned to receive pembrolizumab in combination with the standard non-myeloablative (NMA) conditioning regimen, TIL, and high-dose IL-2 (Arm 2). Patients in Cohort 3 with relative contraindications to pembrolizumab will be assigned to receive standard NMA, TIL, and high dose IL-2 (Arm 3).
- For those patients receiving pembrolizumab, pembrolizumab will be administered immediately prior to TIL administration and continue for an additional three cycles following the cell infusion.
- Up to 53 patients may be enrolled over 3-4 years.
- Conditions
- Melanoma
- Being tested
- young TIL, Pembrolizumab, Aldesleukin, Fludarabine, Cyclophosphamide
- Keywords
- Melanoma, Skin Cancer, Immunotherapy, Cell Therapy
- Medical subject headings
- Melanoma, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
young TILBiological
Day 0: Cells will be administered intravenously (IV) on the Patient Care Unit over 20-30 minutes.
PembrolizumabDrug
(Cohort 1, Arm 2 ,Cohort 2 and Cohort 3, Arm 2) On day -2, and days 21 (+/- 2 days), 42 (+/- 2 days), and 63 (+/- 2 days) following cell infusion: Pembrolizumab 2mg/kg IV over approximately 30 minutes.
AldesleukinDrug
Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 4 days (maximum 12 doses).
FludarabineDrug
Days -7 to -3, Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days.
CyclophosphamideDrug
Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day over 1 hour X 2 days.
| Study group | Role | What they receive |
|---|---|---|
| 1/ACT TIL | Experimental | Non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine +young TIL + highdose aldesleukin (IL-2) Receives: Biological: young TIL; Drug: Aldesleukin; Drug: Fludarabine; Drug: Cyclophosphamide |
| 2/ACT TIL + Pembro | Experimental | Non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine +young TIL + highdose aldesleukin (IL-2) + pembrolizumab Receives: Biological: young TIL; Drug: Pembrolizumab; Drug: Aldesleukin; Drug: Fludarabine; Drug: Cyclophosphamide |
| 3/ACT TIL (Pembro contraindicated) | Experimental | Non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young TIL + highdose aldesleukin (IL-2) Receives: Biological: young TIL; Drug: Aldesleukin; Drug: Fludarabine; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Percentage of patients who have a clinical response to treatment (objective tumor regression)
Measured: 6 and 12 weeks after cell infusion, then every 3 months x3, then every 6 months x 2 years
Secondary outcomes (4)
Frequency and severity of treatment-related adverse events
Aggregate of all adverse events, as well as their frequency and severity
Measured: 30 days after end of treatment
Overall survival
Time from start of treatment to death from any cause
Measured: Time of death
Objective response rate (ORR), progression free survival (PFS) and safety (Cohort 3, Arm 3)
Percentage of patients who have a complete response and/or partial response to treatment
Measured: 6 and 12 weeks after cell infusion, then every 3 months x 3, then every 6 months x 2 years
Overall survival (Cohort 3, Arm 3)
Time from start of treatment to death from any cause
Measured: Time of death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study start4 Dec 2015
- Primary completion16 Jun 2028 (estimated)
- Study completion16 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Stephanie L Goff, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02621021
- Sponsor's protocol ID
- 160027
- Other IDs
- 16-C-0027
- Status last verified
- 18 Aug 2026
- First submitted
- 2 Dec 2015
- Last updated
- 20 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD recorded in the medical record will be shared with intramural investigators upon request.
Publications
Rosenberg SA, Yang JC, Sherry RM, Kammula US, Hughes MS, Phan GQ, Citrin DE, Restifo NP, Robbins PF, Wunderlich JR, Morton KE, Laurencot CM, Steinberg SM, White DE, Dudley ME. Durable complete responses in heavily pretreated patients with metastatic melanoma using T-cell transfer immunotherapy. Clin Cancer Res. 2011 Jul 1;17(13):4550-7. doi: 10.1158/1078-0432.CCR-11-0116. Epub 2011 Apr 15.
PubMed 21498393Robert C, Schachter J, Long GV, Arance A, Grob JJ, Mortier L, Daud A, Carlino MS, McNeil C, Lotem M, Larkin J, Lorigan P, Neyns B, Blank CU, Hamid O, Mateus C, Shapira-Frommer R, Kosh M, Zhou H, Ibrahim N, Ebbinghaus S, Ribas A; KEYNOTE-006 investigators. Pembrolizumab versus Ipilimumab in Advanced Melanoma. N Engl J Med. 2015 Jun 25;372(26):2521-32. doi: 10.1056/NEJMoa1503093. Epub 2015 Apr 19.
PubMed 25891173Besser MJ, Shapira-Frommer R, Itzhaki O, Treves AJ, Zippel DB, Levy D, Kubi A, Shoshani N, Zikich D, Ohayon Y, Ohayon D, Shalmon B, Markel G, Yerushalmi R, Apter S, Ben-Nun A, Ben-Ami E, Shimoni A, Nagler A, Schachter J. Adoptive transfer of tumor-infiltrating lymphocytes in patients with metastatic melanoma: intent-to-treat analysis and efficacy after failure to prior immunotherapies. Clin Cancer Res. 2013 Sep 1;19(17):4792-800. doi: 10.1158/1078-0432.CCR-13-0380. Epub 2013 May 20.
PubMed 23690483
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial for Metastatic Melanoma Using Adoptive Cell Therapy With Tumor-Infiltrating Lymphocytes Plus IL-2 Either Alone or Following the Administration of Pembrolizumab
- ClinicalTrials.gov ID
- NCT02621021
- Acronym / sponsor ID
- 160027
- Conditions
- Melanoma
- Keywords
- Melanoma, Skin Cancer, Immunotherapy, Cell Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 4 Dec 2015 (actual)
- Primary completion
- 16 Jun 2028 (estimated)
- Study completion
- 16 Jun 2029 (estimated)
- First posted
- 3 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Cell therapy is an experimental cancer therapy. It takes young tumor infiltrating lymphocytes (Young TIL) cells from a person s tumors and grows them in a lab. Then they are returned to the person. Researchers think adding the drug pembrolizumab might make the therapy more effective.
Objective:
To test if adding pembrolizumab to cell therapy is safe and effective to shrink melanoma tumors.
Eligibility:
People ages 18-72 years with metastatic melanoma OF THE SKIN
Design:
Participants will be screened with:
Physical exam
CT, MRI, or PET scans
X-rays
Heart and lung function tests if indicated
Blood and urine tests
Before treatment, participants will have:
A piece of tumor taken from a biopsy or during surgery in order to grow TIL cells
Leukapheresis: Blood flows through a needle in one arm and into a machine that removes white blood cells.
The rest of the blood returns through a needle in the other arm.
An IV catheter placed in the chest for getting TIL cells, aldesleukin, and pembrolizumab (if assigned)
Participants will stay in the hospital for treatment. This includes:
Daily chemotherapy for 1 week
For some participants, pembrolizumab infusion 1 day after chemotherapy
TIL cell infusion 2-4 days after chemotherapy, then aldesleukin infusion every 8 hours for up to 12 doses
Filgrastim injections to help restore your blood counts
Recovery for 1-3 weeks
After treatment, participants will:
Take an antibiotic and an antiviral for at least 6 months, as applicable
If assigned, have pembrolizumab treatment every 3 weeks for 3 more doses. They may have another round.
Have 2-day follow-up visits every 1-3 months for 1 year and then every 6 months
Detailed description
Background:
- Adoptive cell therapy (ACT) using autologous tumor infiltrating lymphocytes (TIL) can mediate the regression of bulky metastatic melanoma when administered along with high-dose aldesleukin (IL-2) following a non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine.
- Pembrolizumab, a monoclonal antibody that binds to PD-1 and blocks the PD-1/PD-L1 axis, facilitates the activity of anti-tumor lymphocytes in the tumor micro environment. Pembrolizumab administration can result in objective tumor responses in patients with metastatic melanoma and is approved for use by the FDA for the treatment of these patients.
- Administered TIL express low levels of PD-1, though PD-1 can be re-expressed on TIL in vivo following TIL administration.
- In pre-clinical models, the administration of an anti-PD1 antibody enhances the anti-tumor activity of transferred T-cells.
Objectives:
Primary Objectives:
-Revised Study Design: Determine the objective response rate with the addition of pembrolizumab to the standard non-myeloablative conditioning regimen, TIL, and high-dose IL-2 in patients with metastatic melanoma who have received prior anti-PD-1/PD-L1 therapy (Cohorts 1 and 3).
Original Study Design (retained for historical purposes):
- Determine in a prospective randomized trial whether the addition of pembrolizumab to the standard non-myeloablative conditioning regimen, TIL, and high-dose IL-2 can improve complete response rates in patients with metastatic melanoma who have received prior anti-PD-1/PD-L1 therapy (Cohort 1).
- Determine the complete response rate to the standard non-myeloablative conditioning regimen, TIL, and high-dose IL-2 in combination with pembrolizumab in patients with metastatic melanoma who have not received prior anti-PD-1/PD-L1 therapy (Cohort 2).
Eligibility:
Patients must be/have:
- Age greater than or equal to 18 years and less than or equal to 72 years
- Evaluable metastatic melanoma
- Metastatic melanoma lesion suitable for surgical resection for the preparation of TIL
- No allergies or hypersensitivity to high-dose aldesleukin administration
- No concurrent major medical illnesses or any form of immunodeficiency
Design:
- Patients with metastatic melanoma will have lesions resected for TIL.
- Patients will be assigned to one of three cohorts: (1) patients who are refractory to prior anti-PD-1/PD-L1 therapy (randomized); (2) patients who have not received prior anti-PD-1/PD-L1 therapy; and (3) patients who are refractory to anti PD-1/PD-L1 (nonrandomized). Note: Cohorts 1 and 2 were closed upon the addition of Cohort 3.
- After TIL growth is established:
- Original Study Design:
Patients assigned to Cohort 1 will be randomized to either receive or not receive pembrolizumab in combination with the standard non-myeloablative conditioning regimen, TIL, and high-dose IL-2. All patients assigned to Cohort 2 will receive the standard non-myeloablative conditioning regimen, TIL, and high-dose IL-2 in combination with pembrolizumab.
--Revised Study Design: Patients assigned to Cohort 3 without contraindications to pembrolizumab, will be assigned to receive pembrolizumab in combination with the standard non-myeloablative (NMA) conditioning regimen, TIL, and high-dose IL-2 (Arm 2). Patients in Cohort 3 with relative contraindications to pembrolizumab will be assigned to receive standard NMA, TIL, and high dose IL-2 (Arm 3).
- For those patients receiving pembrolizumab, pembrolizumab will be administered immediately prior to TIL administration and continue for an additional three cycles following the cell infusion.
- Up to 53 patients may be enrolled over 3-4 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1/ACT TIL | Experimental | Biological: young TIL, Drug: Aldesleukin, Drug: Fludarabine, Drug: CyclophosphamideNon-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine +young TIL + highdose aldesleukin (IL-2) |
| 2/ACT TIL + Pembro | Experimental | Biological: young TIL, Drug: Pembrolizumab, Drug: Aldesleukin, Drug: Fludarabine, Drug: CyclophosphamideNon-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine +young TIL + highdose aldesleukin (IL-2) + pembrolizumab |
| 3/ACT TIL (Pembro contraindicated) | Experimental | Biological: young TIL, Drug: Aldesleukin, Drug: Fludarabine, Drug: CyclophosphamideNon-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young TIL + highdose aldesleukin (IL-2) |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (12 listed)
- Individuals of child-bearing potential who are pregnant or nursing because of the potentially dangerous effects of the treatment on the fetus or infant.
- Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).
- Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities.)
- Active systemic infections requiring anti-infective treatment, coagulation disorders or any other active major medical illnesses.
- History of major organ autoimmune disease
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 |
|---|---|---|
| young TILDay 0: Cells will be administered intravenously (IV) on the Patient Care Unit over 20-30 minutes. | Biological | 1/ACT TIL, 2/ACT TIL + Pembro, 3/ACT TIL (Pembro contraindicated) |
| Pembrolizumab(Cohort 1, Arm 2 ,Cohort 2 and Cohort 3, Arm 2) On day -2, and days 21 (+/- 2 days), 42 (+/- 2 days), and 63 (+/- 2 days) following cell infusion: Pembrolizumab 2mg/kg IV over approximately 30 minutes. | Drug | 2/ACT TIL + Pembro |
| AldesleukinAldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 4 days (maximum 12 doses). | Drug | 1/ACT TIL, 2/ACT TIL + Pembro, 3/ACT TIL (Pembro contraindicated) |
| FludarabineDays -7 to -3, Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days. | Drug | 1/ACT TIL, 2/ACT TIL + Pembro, 3/ACT TIL (Pembro contraindicated) |
| CyclophosphamideDays -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day over 1 hour X 2 days. | Drug | 1/ACT TIL, 2/ACT TIL + Pembro, 3/ACT TIL (Pembro contraindicated) |
Primary outcome
Response rate
Time frame: 6 and 12 weeks after cell infusion, then every 3 months x3, then every 6 months x 2 years
Percentage of patients who have a clinical response to treatment (objective tumor regression)
4 secondary outcomes
Frequency and severity of treatment-related adverse events
Time frame: 30 days after end of treatment
Overall survival
Time frame: Time of death
Objective response rate (ORR), progression free survival (PFS) and safety (Cohort 3, Arm 3)
Time frame: 6 and 12 weeks after cell infusion, then every 3 months x 3, then every 6 months x 2 years
Overall survival (Cohort 3, Arm 3)
Time frame: Time of death
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Background: PubMed 21498393Rosenberg SA, Yang JC, Sherry RM, Kammula US, Hughes MS, Phan GQ, Citrin DE, Restifo NP, Robbins PF, Wunderlich JR, Morton KE, Laurencot CM, Steinberg SM, White DE, Dudley ME. Durable complete responses in heavily pretreated patients with metastatic melanoma using T-cell transfer immunotherapy. Clin Cancer Res. 2011 Jul 1;17(13):4550-7. doi: 10.1158/1078-0432.CCR-11-0116. Epub 2011 Apr 15.
- Background: PubMed 25891173Robert C, Schachter J, Long GV, Arance A, Grob JJ, Mortier L, Daud A, Carlino MS, McNeil C, Lotem M, Larkin J, Lorigan P, Neyns B, Blank CU, Hamid O, Mateus C, Shapira-Frommer R, Kosh M, Zhou H, Ibrahim N, Ebbinghaus S, Ribas A; KEYNOTE-006 investigators. Pembrolizumab versus Ipilimumab in Advanced Melanoma. N Engl J Med. 2015 Jun 25;372(26):2521-32. doi: 10.1056/NEJMoa1503093. Epub 2015 Apr 19.
- Background: PubMed 23690483Besser MJ, Shapira-Frommer R, Itzhaki O, Treves AJ, Zippel DB, Levy D, Kubi A, Shoshani N, Zikich D, Ohayon Y, Ohayon D, Shalmon B, Markel G, Yerushalmi R, Apter S, Ben-Nun A, Ben-Ami E, Shimoni A, Nagler A, Schachter J. Adoptive transfer of tumor-infiltrating lymphocytes in patients with metastatic melanoma: intent-to-treat analysis and efficacy after failure to prior immunotherapies. Clin Cancer Res. 2013 Sep 1;19(17):4792-800. doi: 10.1158/1078-0432.CCR-13-0380. Epub 2013 May 20.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD recorded in the medical record will be shared with intramural investigators upon request.
Related trials for Melanoma
Enrolling by invitationObservational study
Community Based Strategies for Early Detection of Melanoma
Melanoma
Active, not recruitingPhase 3
Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8
Active, not recruitingPhase 2
A Study to Compare the Administration of Pembrolizumab After Surgery Versus Administration Both Before and After Surgery for High-Risk Melanoma
Acral Lentiginous Melanoma, Clinical Stage III Cutaneous Melanoma AJCC v8
RecruitingObservational study
Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of Melanoma
Melanoma, Dysplastic Nevus Syndrome
RecruitingPhase 1
A Phase 1 Study to Evaluate OPB-201 in Recurrent Endometrial and Platinum-resistant Ovarian Cancer.
Endometrial Cancer Recurrent, Endometrial Cancer
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.
Stephanie L Goff, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing young TIL, Pembrolizumab and Aldesleukin in people with Melanoma, run by National Cancer Institute (NCI) at 1 site 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 0 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact NCI/Surgery Branch Recruitment Center ((866) 820-4505, IRC@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: 6 and 12 weeks after cell infusion, then every 3 months x3, then every 6 months x 2 years). 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 NCT02621021, which also lists 3 linked publications.
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 Aug 2026.