Status:
TERMINATED
ImmPACT Expanded Multiple Antigen Specific Endogenously Derived T Cells (MASE-T) to Patients With Metastatic Melanoma
Lead Sponsor:
Inge Marie Svane
Collaborating Sponsors:
Technical University of Denmark
Conditions:
Malignant Melanoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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 %, exper...
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 surge...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
- 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)
- 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
Key Trial Info
Start Date :
September 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 7 2024
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04904185
Start Date
September 17 2021
End Date
June 7 2024
Last Update
July 25 2025
Active Locations (1)
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1
National Center for Cancer Immune Therapy (CCIT-DK)
Herlev, Denmark, 2730