Phase 2 N=12 Treatment

Peginterferon and TIL Therapy for Metastatic Melanoma

Metastatic Melanoma

Bottom Line

View on ClinicalTrials.gov: NCT02379195 ↗

Enrolled (actual)

Serious AEs

33.3%

Results posted

Jan 2020

Primary outcome: Primary: Number of Participants With Adverse Events/Serious Adverse Events — 12; 12; 4 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Cyclophosphamide (Drug); Fludarabine (Drug); TIL infusion (Biological); Interleukin-2 (Drug); Peginterferon alfa-2b (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Inge Marie Svane
Primary completion: Jan 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Adverse Events/Serious Adverse Events	12; 12; 4	—
SECONDARY Treatment Related Immune Responses	6	—
SECONDARY Objective Response Rate	2	—
SECONDARY Overall Survival	11.75	—
SECONDARY Progression Free Survival	2.8	—

Summary

Adoptive T cell therapy with tumor infiltrating lymphocytes (TIL) has achieved impressive clinical results with durable complete responses in patients with metastatic melanoma. The TILs are isolated from the patients own tumor tissue followed by in vitro expansion and activation for around 4-6 weeks. Before TIL infusion the patients receive 1 week of preconditioning chemotherapy with cyclophosphamide and fludarabine. After TIL infusion Interleukin-2 are administered to support T cell activation and proliferation in vivo. In this trial the therapy is combined with peginterferon (the pegylated form of interferon alpha 2b). Interferon alpha has immunomodulatory effects and is known to upregulate HLA expression on melanoma cells and are hypothesized to synergize with TIL therapy.

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02379195). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.