Malignant MelanomaPhase 1NCT04904185
ImmPACT Expanded Multiple Antigen Specific Endogenously Derived T Cells (MASE-T) to Patients With Metastatic Melanoma
A Phase 1 study testing Cyclophosphamide, Fludarabine Phosphate and Multiple Antigen Specific Endogenously derived T cells in people with Malignant Melanoma, run by Inge Marie Svane at 1 site in Denmark.
Trial summary
With the introduction of checkpoint inhibitors substantial improvements have been made in the treatment of malignant melanoma (MM). Despite this still a a subset of patients, approximately 50 %, experience no response to therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Malignant Melanoma
- What is being tested?
- Cyclophosphamide, Fludarabine Phosphate and Multiple Antigen Specific Endogenously derived T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteDenmark
- Study dates
- 17 Sep 2021to 7 Jun 2024
- Phase
- Phase 1
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 ≤ 75
- Progressive disease on or after anti-PD-1/anti-PD-L1 monotherapy or progressive disease on or after anti PD-1 plus anti-CTLA-4 therapy
- The patient has histologically confirmed metastatic melanoma
- HLA-A2 positive
- At least one measurable parameter according to RECIST version 1.1 guidelines
- ECOG performance status of 0 or 1
Show all 18Show fewer
- No significant toxicity from previous cancer treatments (CTC ≤ 1)
- Women of childbearing potential: Negative serum pregnancy test and must use effective contraception. This applies from screening and until 6 months after treatment. Birth control pills, spiral, depot injection with gestagen, subdermal implantation, hormonal vaginal ring and transdermal depot patch are all considered effective contraceptives
- Men with female partner of childbearing potential must use effective contraception from screening and until 6 months after treatment. Effective contraceptives are as described above for the female partner. In addition, documented vasectomy and sterility or double barrier contraception are considered effective contraceptives
- Signed statement of consent after receiving oral and written study information
- Willingness to participate in the planned treatment and follow-up and capable of handling
- The patient has met the following haematological and biochemical criteria:
- AST and ALT ≤2,5 X ULN or ≤5 X ULN with liver metastases
- Serum total bilirubin ≤1,5 X ULN or direct bilirubin ≤ ULN for patient with total bilirubin level > 1,5 ULN
- Serum creatinine ≤1,5 X ULN
- ANC (Absolute Neutrophil Count) ≥1,000/mcL
- Platelets ≥ 75,000 /mcL
- Hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L
Who cannot join
- Another malignancy or concurrent malignancy unless disease-free for 3 years
- Requirement for immunosuppressive doses of systemic corticosteroids (>10 mg/day prednisone or equivalent) or other immunosuppressive drugs within the last 3 weeks prior to screening
- Prior treatment with adoptive transfer of Tumor Infiltrating T cells (TIL)
- Grade 3-4 adverse events upon treatment with PD-1 checkpoint inhibitors (only phase B)
- The patient has CNS metastases and/or carcinomatous meningitis
- The patient has any condition that will interfere with patient compliance or safety (including but not limited to psychiatric or substance abuse disorders)
Show all 15Show fewer
- The patient is pregnant or breastfeeding
- The patient has an active infection requiring systemic therapy
- The patient has received a live virus vaccine within 30 days of planned start of therapy
- Significant medical disorder according to investigator; e.g severe asthma or chronic obstructive lung disease, dysregulated heart disease or dysregulated diabetes mellitus.
- Concurrent treatment with other experimental drugs
- Any significant active autoimmune disease
- Severe allergy or anaphylactic reactions earlier in life
- Known hypersensitivity to one of the active drugs or one or more of the excipients.
- Unrelieved lower urinary tract obstruction
Trial locations and contacts
1 site in 1 country.
Denmark1 site
National Center for Cancer Immune Therapy (CCIT-DK)
Herlev, 2730
About this study
Official title: Adoptive Transfer of ImmPACT Expanded Multiple Antigen Specific Endogenously Derived T Cells (MASE-T) in Combination With Lymphodepletion and Anti-PD-1 to Patients With Metastatic Melanoma
With the introduction of checkpoint inhibitors substantial improvements have been made in the treatment of malignant melanoma (MM). Despite this still a a subset of patients, approximately 50 %, experience no response to therapy.
One of the strategies to overcome these obstacles have been ACT with tumour infiltrating lymphocytes (TILs). Most TIL based ACT products are non-specifically expanded providing growth preference to co-infiltrated virus specific T cells, and it is currently challenging to expand T cells in an antigen-specific manner, while at the same time obtaining the ideal functional characteristics for specific and strong tumour-killing capacity with sufficient persistence.
In this phase I trial artificial antigen-presenting scaffolds for antigen-driven T cell expansion are used. These scaffolds will generate a MASE-T cell product enriched for selected specificities towards antigens known to be expressed by melanoma cells The aim of the study is to demonstrate that treatment with af MASE-T cell product i safe and feasible. Further the study will elucidate whether treament with the MASE-T cell product leads to objective responses and improves progression free survival (PFS).
Read the detailed description
There are around 350-400 new cases of patients with metastatic melanoma (MM) per year in Denmark. MM is a very aggressive cancer with a poor prognosis. Traditional oncological treatments such as surgery, chemotherapy and radiation therapy have a poor effect, and the 5-year overall survival has hitherto been less than 10 %.Substantial improvements have been made in the treatment of MM; especially immunotherapy is showing promising results with checkpoint inhibitors (CPI) such as programmed cell death protein 1 (PD-1) and Cytotoxic T Lymphocyte-associated Antigen 4 (CTLA-4) blocking antibodies administered as standard treatment in the frontline. The 5-year overall survival has now reached 52 %, 44 % and 26 % in nivolumab/ipilimumab, nivolumab, and ipilimumab respectively. However, a subset of patients - approximately 50 % experience no response to therapy, with clear primary resistance. One of the strategies to overcome these obstacles have been ACT with tumour infiltrating lymphocytes (TILs). A crucial condition for optimal ACT based on TILs is the generation of sufficient numbers of tumourreactive T cells. However, the expansion of TILs requires extensive ex vivo culturing often at the cost of T cell differentiation and functional activity. Most TIL based ACT products are non-specifically expanded providing growth preference to co-infiltrated virus specific T cells, and it is currently challenging to expand T cells in an antigen-specific manner, while at the same time obtaining the ideal functional characteristics for specific and strong tumour-killing capacity with sufficient persistence. Recent data suggest that the majority of tumour specific T cells responsible for tumour rejection under CPI are recruited from peripheral blood and lymph system, while not present in the tumour prior to treatment. This is supported by the finding that most tumour resident T cells are dysfunctional.
To overcome the current limitations in the treatment of malignant melanoma artificial antigen-presenting scaffolds for antigen-driven T cell expansion, generating a MASE-T cell product enriched for selected specificities towards antigens known to be expressed by melanoma cells has been designed. The antigen-scaffolds will ensuring optimal T cell stimulation by mimicking the in vivo stimulation of T cells by dendritic cells in the lymph nodes. The scaffolds contain both the antigen specific element - in the form of a peptide-MHC molecule and cytokine (IL2 and IL21), to provide growth and functional signals to the antigen specific T cell. As a result of this T cell expansion strategy, we can obtain a T cell product enriched for tumourantigen specific T cells. Superior functional activity towards tumor cells and antigen recognition compared to conventional T cell expansion strategies has been demonstrated in-vitro. Importantly, antigen-specific T cells in the MASE-T cell product possess a 'younger' phenotype, which has previously been described to correlate with improved in vivo persistence.
The study is a phase 1, non-randomized study. The trial will be conducted in two parts (A and B). Patients will be treated as followed:
- Part A (6 patients): Lymphodepleting chemotherapy (cyclophosphamide 500 mg/m2/day i.v. on day -4, -3, -2 and fludarabine 30 mg/m2/day i.v. on day -4, -3) followed by i.v. infusion of the MASE-T product on day 0. If the production of the MASE-T cell product was feasible for the majority (≥50%) of patients intended to treat in Arm A and the toxicity was acceptable, six patients will further be included in part B.
- Part B (6 patients): Lymphodepleting chemotherapy (cyclophosphamide 500 mg/m2/day i.v. on day -4, -3, -2 and fludarabine 30 mg/m2/day i.v on day -4, -3) followed by i.v infusion of the MASE-T product on day 0. Pembrolizumab 2 mg/kg will be administered on day -1 and day +21.
The primary objective is to evaluate the safety and feasibility of the MASE-T treatment alone or in combination with Pembrolizumab in patients with stage IV metastatic melanoma according to Common Terminology Criteria for Adverse Events (CTCAE version 5.0).
The secondary objectives are to evaluate T cell profile and persistence in vivo from tumor biopsies and blood samples as well as evaluation of the clinical efficacy of the treatment according to RECIST 1.1 and iRECIST. In addition, best overall response (BOR), duration of response (DOR), overall survival (OS), progression-free survival (PFS) will be monitored.
- Conditions
- Malignant Melanoma
- Being tested
- Cyclophosphamide, Fludarabine Phosphate, Multiple Antigen Specific Endogenously derived T cells, Pembrolizumab
- Keywords
- Adoptive Cell Therapy, Immune Therapy, Multiple Antigen Specific Endogenously derived T cells
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
Cyclophosphamide 500 mg/m2 is administered i.v. on day -4, -3 and -2
Fludarabine Phosphate 30 mg/m2 is administered on day -4 and -3
Multiple Antigen Specific Endogenously derived T cellsBiological
Also called MASE-T
Antigen specific, ex vivo expanded T cells derived from peripheral blood T cells
PembrolizumabDrug
Pembrolizumab 2 mg/kg is administered on day -1 and on day 21. The medicine is administered over 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| Part A | Other | Six patients will be included in Part A. After inclusion 300 mL blood will be drawn from the patients for the production of the MASE-T cell product. Four days prior to MASE-T infusion the patient will receive lymphodepleting chemotherapy (cyclophosphamide 500 mg/m2/day i.v. on day -4, -3, -2 and fludarabine 30 mg/m2/day i.v. on day -4, -3) followed by i.v. infusion of the MASE-T product on day 0. Receives: Drug: Cyclophosphamide; Drug: Fludarabine Phosphate; Biological: Multiple Antigen Specific Endogenously derived T cells |
| Part B | Other | Six patients will be includede in Part B. After inclusion 300 mL blood will be drawn from the patients for the production of the MASE-T cell product. Four days prior to MASE-T infusion the patient will receive lymphodepleting chemotherapy (cyclophosphamide 500 mg/m2/day i.v. on day -4, -3, -2 and fludarabine 30 mg/m2/day i.v on day -4, -3) followed by i.v infusion of the MASE-T product on day 0. Pembrolizumab 2 mg/kg will be administered on day -1 and day +21. Receives: Drug: Cyclophosphamide; Drug: Fludarabine Phosphate; Biological: Multiple Antigen Specific Endogenously derived T cells; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability of the Treatment
Number of patients experiencing grade III or worse adverse events. The grading of adverse events was performed according to CTCAE ver. 5.0.
Measured: Through study completion, up to 2.8 years from begin of study
Number of Patients Excluded Due to Feasibility Issues
Number of patients excluded due to treatment related feasibility issues compared to the number of patients enrolled in the study.
Measured: Through study completion, up to 2.8 years from begin of study
Number of Patients Excluded Due to Safety Issues
Number of patients excluded due to treatment related safety issues compared to the number of patients enrolled in the study.
Measured: Through study completion, up to 2.8 years from begin of study
Secondary outcomes (1)
Best Overall Response (BOR)
Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1) assessed by CT scan.
Complete Response (CR): Disappearance of all target lesions Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions Progressive disease: >= 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions Stable disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study
Measured: The patients were evaluated every 6-12 weeks until study completion (minimum: 43 days, median: 69 days, maximum: 128 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start17 Sep 2021
- Primary completion7 Jun 2024
- Study completion7 Jun 2024
Why it stopped: Evaluation of step A did not support addition of pembrolizumab in step B
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.
- Other trials for Malignant MelanomaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 12 Patients will be indluced in two steps. * Part A (6 patients): Lymphodepleting chemotherapy (cyclophosphamide 500 mg/m2/day i.v. on day -4, -3, -2 and fludarabine 30 mg/m2/day i.v. on day -4, -3) followed by i.v. infusion of the MASE-T product on day 0. If the production of the MASE-T cell product was feasible for the majority (\>50%) of patients intended to treat in Arm A and the toxicity was acceptable, six patients will further be included in part B. * Part B (6 patients): Lymphodepleting chemotherapy (cyclophosphamide 500 mg/m2/day i.v. on day -4, -3, -2 and fludarabine 30 mg/m2/day i.v on day -4, -3) followed by i.v infusion of the MASE-T product on day 0. Pembrolizumab 2 mg/kg will be administered on day -1 and day +21.
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inge Marie Svane
- Sponsor type
- University, hospital or other
- Collaborators
- Technical University of Denmark
- Responsible party
- Sponsor-investigator, Inge Marie Svane, Herlev Hospital
- Investigators
- Inge M Svane, Prof., M.D., Study director, Study Director, National Center for Cancer Immune Therapy, Depth of Oncology, Herlev HospitalTine J Monberg, M.D., Principal investigator, Ph.d. student, National Center for Cancer Immune Therapy, Depth of Oncology, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04904185
- Sponsor's protocol ID
- MM2011
- Status last verified
- Jul 2025
- First submitted
- 22 May 2021
- Last updated
- 25 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adoptive Transfer of ImmPACT Expanded Multiple Antigen Specific Endogenously Derived T Cells (MASE-T) in Combination With Lymphodepletion and Anti-PD-1 to Patients With Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT04904185
- Acronym / sponsor ID
- MM2011
- Conditions
- Malignant Melanoma
- Keywords
- Adoptive Cell Therapy, Immune Therapy, Multiple Antigen Specific Endogenously derived T cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Evaluation of step A did not support addition of pembrolizumab in step B
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Inge Marie SvaneUniversity, hospital or other
- Collaborators
- Technical University of Denmark
- Study start
- 17 Sep 2021 (actual)
- Primary completion
- 7 Jun 2024 (actual)
- Study completion
- 7 Jun 2024 (actual)
- First posted
- 27 May 2021 (actual)
- Results
- Posted 25 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
With the introduction of checkpoint inhibitors substantial improvements have been made in the treatment of malignant melanoma (MM). Despite this still a a subset of patients, approximately 50 %, experience no response to therapy.
One of the strategies to overcome these obstacles have been ACT with tumour infiltrating lymphocytes (TILs). Most TIL based ACT products are non-specifically expanded providing growth preference to co-infiltrated virus specific T cells, and it is currently challenging to expand T cells in an antigen-specific manner, while at the same time obtaining the ideal functional characteristics for specific and strong tumour-killing capacity with sufficient persistence.
In this phase I trial artificial antigen-presenting scaffolds for antigen-driven T cell expansion are used. These scaffolds will generate a MASE-T cell product enriched for selected specificities towards antigens known to be expressed by melanoma cells The aim of the study is to demonstrate that treatment with af MASE-T cell product i safe and feasible. Further the study will elucidate whether treament with the MASE-T cell product leads to objective responses and improves progression free survival (PFS).
Detailed description
There are around 350-400 new cases of patients with metastatic melanoma (MM) per year in Denmark. MM is a very aggressive cancer with a poor prognosis. Traditional oncological treatments such as surgery, chemotherapy and radiation therapy have a poor effect, and the 5-year overall survival has hitherto been less than 10 %.Substantial improvements have been made in the treatment of MM; especially immunotherapy is showing promising results with checkpoint inhibitors (CPI) such as programmed cell death protein 1 (PD-1) and Cytotoxic T Lymphocyte-associated Antigen 4 (CTLA-4) blocking antibodies administered as standard treatment in the frontline. The 5-year overall survival has now reached 52 %, 44 % and 26 % in nivolumab/ipilimumab, nivolumab, and ipilimumab respectively. However, a subset of patients - approximately 50 % experience no response to therapy, with clear primary resistance. One of the strategies to overcome these obstacles have been ACT with tumour infiltrating lymphocytes (TILs). A crucial condition for optimal ACT based on TILs is the generation of sufficient numbers of tumourreactive T cells. However, the expansion of TILs requires extensive ex vivo culturing often at the cost of T cell differentiation and functional activity. Most TIL based ACT products are non-specifically expanded providing growth preference to co-infiltrated virus specific T cells, and it is currently challenging to expand T cells in an antigen-specific manner, while at the same time obtaining the ideal functional characteristics for specific and strong tumour-killing capacity with sufficient persistence. Recent data suggest that the majority of tumour specific T cells responsible for tumour rejection under CPI are recruited from peripheral blood and lymph system, while not present in the tumour prior to treatment. This is supported by the finding that most tumour resident T cells are dysfunctional.
To overcome the current limitations in the treatment of malignant melanoma artificial antigen-presenting scaffolds for antigen-driven T cell expansion, generating a MASE-T cell product enriched for selected specificities towards antigens known to be expressed by melanoma cells has been designed. The antigen-scaffolds will ensuring optimal T cell stimulation by mimicking the in vivo stimulation of T cells by dendritic cells in the lymph nodes. The scaffolds contain both the antigen specific element - in the form of a peptide-MHC molecule and cytokine (IL2 and IL21), to provide growth and functional signals to the antigen specific T cell. As a result of this T cell expansion strategy, we can obtain a T cell product enriched for tumourantigen specific T cells. Superior functional activity towards tumor cells and antigen recognition compared to conventional T cell expansion strategies has been demonstrated in-vitro. Importantly, antigen-specific T cells in the MASE-T cell product possess a 'younger' phenotype, which has previously been described to correlate with improved in vivo persistence.
The study is a phase 1, non-randomized study. The trial will be conducted in two parts (A and B). Patients will be treated as followed:
- Part A (6 patients): Lymphodepleting chemotherapy (cyclophosphamide 500 mg/m2/day i.v. on day -4, -3, -2 and fludarabine 30 mg/m2/day i.v. on day -4, -3) followed by i.v. infusion of the MASE-T product on day 0. If the production of the MASE-T cell product was feasible for the majority (≥50%) of patients intended to treat in Arm A and the toxicity was acceptable, six patients will further be included in part B.
- Part B (6 patients): Lymphodepleting chemotherapy (cyclophosphamide 500 mg/m2/day i.v. on day -4, -3, -2 and fludarabine 30 mg/m2/day i.v on day -4, -3) followed by i.v infusion of the MASE-T product on day 0. Pembrolizumab 2 mg/kg will be administered on day -1 and day +21.
The primary objective is to evaluate the safety and feasibility of the MASE-T treatment alone or in combination with Pembrolizumab in patients with stage IV metastatic melanoma according to Common Terminology Criteria for Adverse Events (CTCAE version 5.0).
The secondary objectives are to evaluate T cell profile and persistence in vivo from tumor biopsies and blood samples as well as evaluation of the clinical efficacy of the treatment according to RECIST 1.1 and iRECIST. In addition, best overall response (BOR), duration of response (DOR), overall survival (OS), progression-free survival (PFS) will be monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 12 Patients will be indluced in two steps. * Part A (6 patients): Lymphodepleting chemotherapy (cyclophosphamide 500 mg/m2/day i.v. on day -4, -3, -2 and fludarabine 30 mg/m2/day i.v. on day -4, -3) followed by i.v. infusion of the MASE-T product on day 0. If the production of the MASE-T cell product was feasible for the majority (>50%) of patients intended to treat in Arm A and the toxicity was acceptable, six patients will further be included in part B. * Part B (6 patients): Lymphodepleting chemotherapy (cyclophosphamide 500 mg/m2/day i.v. on day -4, -3, -2 and fludarabine 30 mg/m2/day i.v on day -4, -3) followed by i.v infusion of the MASE-T product on day 0. Pembrolizumab 2 mg/kg will be administered on day -1 and day +21.
| Arm | Type | Receives |
|---|---|---|
| Part A | Other | Drug: Cyclophosphamide, Drug: Fludarabine Phosphate, Biological: Multiple Antigen Specific Endogenously derived T cellsSix patients will be included in Part A. After inclusion 300 mL blood will be drawn from the patients for the production of the MASE-T cell product. Four days prior to MASE-T infusion the patient will receive lymphodepleting chemotherapy (cyclophosphamide 500 mg/m2/day i.v. on day -4, -3, -2 and fludarabine 30 mg/m2/day i.v. on day -4, -3) followed by i.v. infusion of the MASE-T product on day 0. |
| Part B | Other | Drug: Cyclophosphamide, Drug: Fludarabine Phosphate, Biological: Multiple Antigen Specific Endogenously derived T cells, Drug: PembrolizumabSix patients will be includede in Part B. After inclusion 300 mL blood will be drawn from the patients for the production of the MASE-T cell product. Four days prior to MASE-T infusion the patient will receive lymphodepleting chemotherapy (cyclophosphamide 500 mg/m2/day i.v. on day -4, -3, -2 and fludarabine 30 mg/m2/day i.v on day -4, -3) followed by i.v infusion of the MASE-T product on day 0. Pembrolizumab 2 mg/kg will be administered on day -1 and day +21. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age ≥ 18 ≤ 75
- Progressive disease on or after anti-PD-1/anti-PD-L1 monotherapy or progressive disease on or after anti PD-1 plus anti-CTLA-4 therapy
- The patient has histologically confirmed metastatic melanoma
- HLA-A2 positive
- At least one measurable parameter according to RECIST version 1.1 guidelines
Key exclusion criteria (15 listed)
- Another malignancy or concurrent malignancy unless disease-free for 3 years
- Requirement for immunosuppressive doses of systemic corticosteroids (>10 mg/day prednisone or equivalent) or other immunosuppressive drugs within the last 3 weeks prior to screening
- Prior treatment with adoptive transfer of Tumor Infiltrating T cells (TIL)
- Grade 3-4 adverse events upon treatment with PD-1 checkpoint inhibitors (only phase B)
- The patient has CNS metastases and/or carcinomatous meningitis
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 |
|---|---|---|
| CyclophosphamideCyclophosphamide 500 mg/m2 is administered i.v. on day -4, -3 and -2 | Drug | Part A, Part B |
| Fludarabine PhosphateFludarabine Phosphate 30 mg/m2 is administered on day -4 and -3 | Drug | Part A, Part B |
| Multiple Antigen Specific Endogenously derived T cellsAlso: MASE-TAntigen specific, ex vivo expanded T cells derived from peripheral blood T cells | Biological | Part A, Part B |
| PembrolizumabPembrolizumab 2 mg/kg is administered on day -1 and on day 21. The medicine is administered over 30 minutes | Drug | Part B |
Primary outcome
Tolerability of the Treatment
Time frame: Through study completion, up to 2.8 years from begin of study
Number of patients experiencing grade III or worse adverse events. The grading of adverse events was performed according to CTCAE ver. 5.0.
Number of Patients Excluded Due to Feasibility Issues
Time frame: Through study completion, up to 2.8 years from begin of study
Number of patients excluded due to treatment related feasibility issues compared to the number of patients enrolled in the study.
Number of Patients Excluded Due to Safety Issues
Time frame: Through study completion, up to 2.8 years from begin of study
Number of patients excluded due to treatment related safety issues compared to the number of patients enrolled in the study.
1 secondary outcome
Best Overall Response (BOR)
Time frame: The patients were evaluated every 6-12 weeks until study completion (minimum: 43 days, median: 69 days, maximum: 128 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Melanoma
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.
Inge M Svane, Prof., M.D. study director
Study Director, National Center for Cancer Immune Therapy, Depth of Oncology, Herlev Hospital
Tine J Monberg, M.D. principal investigator
Ph.d. student, National Center for Cancer Immune Therapy, Depth of Oncology, Herlev Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cyclophosphamide, Fludarabine Phosphate and Multiple Antigen Specific Endogenously derived T cells in people with Malignant Melanoma, run by Inge Marie Svane at 1 site in Denmark.
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 18 inclusion and 15 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: stopped early, as of the sponsor's last update on 25 Jul 2025. 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 Denmark. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 25 Jul 2025). 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?
Tolerability of the Treatment (time frame: Through study completion, up to 2.8 years from begin of study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jul 2025.