Mode
Text Size
Log in / Sign up
Phase 2 N=28 Treatment

Testing the Combination of Two Experimental Drugs MK-3475 (Pembrolizumab) and Interferon-gamma for the Treatment of Mycosis Fungoides and Sézary Syndrome and Advanced Synovial Sarcoma

Metastatic Myxoid Liposarcoma · Metastatic Round Cell Liposarcoma · Metastatic Synovial Sarcoma · Recurrent Mycosis Fungoides and Sezary Syndrome · Refractory Mycosis Fungoides and Sezary Syndrome

Enrolled (actual)
28
Serious AEs
32.1%
Results posted
Aug 2022
Primary outcome: Primary: Overall Response Rate (ORR) — 6; 0 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Interferon Gamma-1b (Biological); Laboratory Biomarker Analysis (Other); Pembrolizumab (Biological)
Age
Pediatric, Adult, Older Adult · 12+ yrs
Sex
All
Sponsor
National Cancer Institute (NCI)
Primary completion
Apr 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
Overall Response Rate (ORR)
6; 0
SECONDARY
Incidence of Adverse Events
15; 12
SECONDARY
Time to Response (TTR)
126
SECONDARY
Duration of Response (DOR)
505.0
SECONDARY
Progression-free Survival (PFS)
394.0; 196.5
SECONDARY
Event-free Survival (EFS)
185.5; 73.0
SECONDARY
Rate of Overall Response Duration Beyond 12 Months (ORR12)
2; 0

Summary

This phase II trial studies how well pembrolizumab and interferon gamma-1b work in treating patients with stage IB-IVB mycosis fungoides and Sezary syndrome that has come back (relapsed) or has not responded to previous treatment (refractory). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Interferon gamma-1b may boost the immune system activity. Giving pembrolizumab and interferon gamma-1b together may work better in treating patients with stage IB-IVB mycosis fungoides and Sezary syndrome.

Eligibility Criteria

Inclusion Criteria

  • MYCOSIS FUNGOIDES /SEZARY SYNDROME (TREATMENT GROUP I)
  • Stage IB-IVB Mycosis Fungoides or Sezary syndrome, and who have relapsed, are refractory, or progressed after at least one standard systemic therapy; maximal stage since diagnosis will determine eligibility; current disease stage at time of entry will also be documented but will not be used for eligibility
  • Subjects must have the following minimum wash-out from previous treatments and without treatment between documentation of relapse/progression and enrollment:
  • >= 2 weeks for local radiation therapy
  • >= 8 weeks for low dose (12 Gy or less) Total Skin Electron Beam Therapy (TSEBT)
  • >= 4 weeks for systemic cytotoxic anticancer agents, anticancer investigational agents that are not defined as immunotherapy, or for tumor-targeting monoclonal antibodies (mAbs) with the exception of alemtuzumab for which the washout is at least 16 weeks
  • >= 15 weeks for anti-CD137 or anti-CTLA-4 (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
  • >= 2 weeks from resolution (i.e., = 2 weeks for retinoids, interferons, vorinostat, romidepsin and denileukin diftitox
  • >= 4 weeks for doses of systemic corticosteroids greater than 10 mg/day of prednisone or equivalent; patients who are on physiologic doses of corticosteroids (prednisone equivalent 10 mg/day or less) may participate, however, they must be on a stable dose for at least 4 weeks before enrollment; patients who are on low or moderate potency topical corticosteroids may participate if they are on a stable dose for at least 4 weeks before enrollment; inhaled corticosteroids are acceptable; local injections of corticosteroids are acceptable; all corticosteroids will be reported as concomitant medications
  • >= 2 weeks for phototherapy
  • >= 1 week for topical therapy (including retinoid, nitrogen mustard, or imiquimod)
  • Patients with prior treatment with IFN-gamma will be eligible, if they previously tolerated IFN-gamma, however patients must be off of IFN-gamma for at least three weeks before initiation of therapy on this trial
  • Age >= 18 years
  • Have measurable disease based on modified severity-weighted assessment tool (mSWAT); tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
  • Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale
  • Absolute neutrophil count (ANC) >= 1500/mcL (performed within 10 days of treatment initiation)
  • Platelets >= 100000/mcL (performed within 10 days of treatment initiation)
  • Hemoglobin >= 9 g/dL or >= 5.6 mmol/L (performed within 10 days of treatment initiation)
  • Creatinine = = 60 mL/min for patient with creatinine levels > 1.5 x institutional ULN (performed within 10 days of treatment initiation)
  • Creatinine clearance (CrCl) should be calculated per institutional standard; glomerular filtration rate (GFR) can also be used in place of creatinine or CrCl
  • Total bilirubin = 1.5 x ULN (performed within 10 days of treatment initiation)
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) = = 12 years; patients >= 18 years of age must be able and willing to provide informed consent; patients under 18 years of age must have a parent or guardian willing and able to provide consent
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
  • Life expectancy greater than or equal to (>=) 12 weeks
  • Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
  • Tumor safely accessible for biopsy
  • Adequate hematologic and end organ function
  • For female participants of childbearing potential and male participants with partners of childbearing potential, agreement (by participant and/or partner) to use highly effectiv
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03063632). 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.

Back to search