Peginterferon and TIL Therapy for Metastatic Melanoma

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02379195
• Date of registration: 27/02/2015
• Prospective Registration: No
• Primary sponsor: Inge Marie Svane
• Public title: Peginterferon and TIL Therapy for Metastatic Melanoma
• Scientific title: T Cell Therapy in Combination With Peginterferon for Patients With Metastatic Melanoma
• Date of first enrolment: November 2014
• Target sample size: 12
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02379195
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

Denmark

Contacts

• Name: Inge Marie Svane, Prof, PhD, MD
• Affiliation: Center for Cancer Immune Therapy, Dept of Hematology/Oncology, Copenhagen University Hospital Herlev, Herlev Ringvej 75, DK-2730 Herlev, Denmark

• Name: Rikke Andersen, MD
• Affiliation: Center for Cancer Immune Therapy, Dept of Hematology/Oncology, Copenhagen University Hospital Herlev, Herlev Ringvej 75, DK-2730 Herlev, Denmark

Key inclusion & exclusion criteria

Inclusion Criteria:

Histologically confirmed unresectable stage III or stage IV metastatic melanoma Metastasis
available for surgical resection (about 2 cm3) and residual measurable disease after
resection

ECOG performance status 0-1

Life expectancy = 3 months

No significant toxicity from prior treatments

Adequate renal, hepatic and hematologic function

Women of childbearing potential (WOCBP) and men in a sexual relationship with a WOCBP must
be using an effective method of contraception during treatment and for at least 6 months
after completion af treatment.

Able to comprehend the information given and willing to sign informed consent

-

Exclusion Criteria:

Other Malignancies, unless followed for = 5 years with no sign of disease, except squamous
cell carcinoma or adequately treated carcinoma in situ colli uteri.

Cerebral metastasis. Patients with previously treated CNS metastases can participate if CNS
metastases are surgically removed or treated with stereotactic radiosurgery and stable = 28
days after treatment measured by MRI. Patients with asymptomatic, stable and untreated CNS
metastasis can in be included according to investigators and sponsors decision.

Patients with ocular melanoma

Severe allergies, history of anaphylaxis or known allergies to the administered drugs.

Serious medical or psychiatric comorbidity

Creatinine clearance < 70 ml/min

Acute or chronic infection with e.g. HIV, hepatitis, tuberculosis

Severe and active autoimmune disease

Pregnant and nursing women

Need for immunosuppressive treatment, e.g. corticosteroids or methotrexate

Concomitant treatment with other experimental drugs

Patients with uncontrolled hypercalcemia

Less than four weeks since prior systemic antineoplastic treatment at the time of
treatment.

-



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Metastatic Melanoma

Intervention(s)

Drug: Fludarabine

Drug: Cyclophosphamide

Drug: Peginterferon alfa-2b

Biological: TIL infusion

Drug: Interleukin-2

Primary Outcome(s)

Number of Participants With Adverse Events/Serious Adverse Events [Time Frame: 0-24 weeks]

Secondary Outcome(s)

Objective Response Rate [Time Frame: Up to 36 months]

Progression Free Survival [Time Frame: Up to 36 months]

Overall Survival [Time Frame: Up to 36 months]

Treatment Related Immune Responses [Time Frame: Up to 12 months]

Secondary ID(s)

MM1413

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 22/01/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02379195