Who is sponsoring NCT03063632?

NCT03063632 is sponsored by National Cancer Institute (NCI).

What drugs are being tested in NCT03063632?

Interventions in NCT03063632: Interferon Gamma-1b, Laboratory Biomarker Analysis, Pembrolizumab.

What condition does NCT03063632 study?

NCT03063632 studies Metastatic Myxoid Liposarcoma, Metastatic Round Cell Liposarcoma, Metastatic Synovial Sarcoma, Recurrent Mycosis Fungoides and Sezary Syndrome, Refractory Mycosis Fungoides and Sezary Syndrome, Stage IB Mycosis Fungoides and Sezary Syndrome AJCC v7, Stage II Mycosis Fungoides and Sezary Syndrome AJCC v7, Stage IIA Mycosis Fungoides and Sezary Syndrome AJCC v7, Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v7, Stage III Mycosis Fungoides and Sezary Syndrome AJCC v7, Stage IIIA Mycosis Fungoides and Sezary Syndrome AJCC v7, Stage IIIB Mycosis Fungoides and Sezary Syndrome AJCC v7, Stage IV Mycosis Fungoides and Sezary Syndrome AJCC v7, Stage IVA Mycosis Fungoides and Sezary Syndrome AJCC v7, Stage IVB Mycosis Fungoides and Sezary Syndrome AJCC v7, Unresectable Synovial Sarcoma.

Is NCT03063632 still recruiting?

NCT03063632 is currently completed. Last updated 25 October 2023.

Are results published for NCT03063632?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-10-25 · How we verify

NCT03063632

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Results posted Last updated 25 October 2023

What this trial tests

Phase 2 trial testing Interferon Gamma-1b in Metastatic Myxoid Liposarcoma in 28 participants. Completed in 14 March 2023.

Timeline

14 December 2017

Primary endpoint
8 April 2021

14 March 2023

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	28
Start date	14 December 2017
Primary completion	8 April 2021
Estimated completion	14 March 2023
Sites	7 locations across United States

Drugs / interventions tested

Interferon Gamma-1b — full drug profile →
Laboratory Biomarker Analysis — full drug profile →
Pembrolizumab (pembrolizumab) — full drug profile →

Conditions studied

Metastatic Myxoid Liposarcoma — all drugs for Metastatic Myxoid Liposarcoma →
Metastatic Round Cell Liposarcoma — all drugs for Metastatic Round Cell Liposarcoma →
Metastatic Synovial Sarcoma — all drugs for Metastatic Synovial Sarcoma →
Recurrent Mycosis Fungoides and Sezary Syndrome — all drugs for Recurrent Mycosis Fungoides and Sezary Syndrome →

Sponsor

National Cancer Institute (NCI)

Who can join

12 and older, any sex, with Metastatic Myxoid Liposarcoma or Metastatic Round Cell Liposarcoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Overall Response Rate (ORR) Primary · Up to 2 years

Participants in Treatment Group 1 will be assessed for response and progression using standard response criteria in patients with Mycosis Fungoides and Sezary syndrome. Per Global Response Score determined by evaluating skin, lymph nodes, internal organs (viscera), and blood specimens: Complete Response (CR), complete disappearance of all clinical evidence of disease; Partial Response (PR), regression of measurable disease. Participants in Treatment Group 2 will be assessed for response and progression using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Complete Response

Group	Value	95% CI
Group I (Pembrolizumab, Interferon Gamma-1b)	6
Group II (Pembrolizumab, Interferon Gamma-1b)	0

Incidence of Adverse Events Secondary · Up to 2 years and 1 months

Will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Group	Value	95% CI
Group I (Pembrolizumab, Interferon Gamma-1b)	15
Group II (Pembrolizumab, Interferon Gamma-1b)	12

Time to Response (TTR) Secondary · Time interval between the date of first treatment and the date of response (complete response [CR]/partial response [PR]), up to 2 years

Will use simple statistics.

Group	Value	95% CI
Group I (Pembrolizumab, Interferon Gamma-1b)	126	106 – 463

Duration of Response (DOR) Secondary · Time interval between the date of first response (CR/PR) and the date of progression, up to 2 years and 11 months

Will be assessed using the Kaplan-Meier method.

Group	Value	95% CI
Group I (Pembrolizumab, Interferon Gamma-1b)	505.0	106.0 – NA

Progression-free Survival (PFS) Secondary · Time from enrollment to disease progression or death, whichever occurs earlier, based upon investigator assessment, up to 3 years

Will be assessed using the Kaplan-Meier method

Group	Value	95% CI
Group I (Pembrolizumab, Interferon Gamma-1b)	394.0	120.0 – 615.0
Group II (Pembrolizumab, Interferon Gamma-1b)	196.5	32.0 – NA

Event-free Survival (EFS) Secondary · Termination due to toxicity, initiation of next significant treatment, progressive disease, or death of any cause, up to 2 years

Will be assessed using the Kaplan-Meier method.

Group	Value	95% CI
Group I (Pembrolizumab, Interferon Gamma-1b)	185.5	120.0 – 394.0
Group II (Pembrolizumab, Interferon Gamma-1b)	73.0	32.0 – NA

Rate of Overall Response Duration Beyond 12 Months (ORR12) Secondary · From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date beyond 12 months that recurrent disease is objectively documented, up to 2 years

Will be assessed per global assessment of mycosis fungoides and Sezary syndrome (confirmed \& investigator assessed). Will use binomial distribution.

Group	Value	95% CI
Group I (Pembrolizumab, Interferon Gamma-1b)	2
Group II (Pembrolizumab, Interferon Gamma-1b)	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Group I (Pembrolizumab, Interferon Gamma-1b)

Serious: 4/16 (25%)

Deaths: 4/16

Group II (Pembrolizumab, Interferon Gamma-1b)

Serious: 5/12 (42%)

Deaths: 6/12

Serious adverse events (23 terms)

Reaction	System	Group I (Pembrolizumab, In…	Group II (Pembrolizumab, I…
Soft tissue infection	Infections and infestations	—	—
Bone infection	Infections and infestations	—	—
Urinary tract Infection	Infections and infestations	—	—
Headache	Nervous system disorders	—	—
Hypercalcemia	Metabolism and nutrition disorders	—	—
Acute kidney injury	Renal and urinary disorders	—	—
Atrial fibrillation	Cardiac disorders	—	—
Pericardial tamponade	Cardiac disorders	—	—
Cardiac arrest	Cardiac disorders	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Edema limbs	General disorders	—	—
Disease progression	General disorders	—	—
Fatigue	General disorders	—	—
Fever	General disorders	—	—
Pneumothorax	Respiratory, thoracic and mediastinal disorders	—	—
Lymphocyte count decreased	Investigations	—	—
Alanine aminotransferase increased	Investigations	—	—
Aspartate aminotransferase increased	Investigations	—	—
Tumor pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
Spinal cord compression	Nervous system disorders	—	—

Other adverse events (98 terms — click to expand)

Reaction	System	Group I (Pembrolizumab, In…	Group II (Pembrolizumab, I…
Anemia	Blood and lymphatic system disorders	—	—
Chills	General disorders	—	—
Lymphocyte count decreased	Investigations	—	—
Fatigue	General disorders	—	—
Fever	General disorders	—	—
Flu like symptoms	General disorders	—	—
Skin and subcutaneous tissue disorders - Other	Skin and subcutaneous tissue disorders	—	—
Diarrhea	Gastrointestinal disorders	—	—
Headache	Nervous system disorders	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—
Rash maculo-papular	Skin and subcutaneous tissue disorders	—	—
Tumor pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—
Creatinine increased	Investigations	—	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—	—
Hypokalemia	Metabolism and nutrition disorders	—	—
Hyponatremia	Metabolism and nutrition disorders	—	—
INR increased	Investigations	—	—
Platelet count decreased	Investigations	—	—
Surgical and medical procedures - Other	Surgical and medical procedures	—	—
Anorexia	Metabolism and nutrition disorders	—	—
Aspartate aminotransferase increased	Investigations	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Dehydration	Metabolism and nutrition disorders	—	—
Depression	Psychiatric disorders	—	—
Edema limbs	General disorders	—	—
Hyperglycemia	Metabolism and nutrition disorders	—	—
Hyperkalemia	Metabolism and nutrition disorders	—	—
Hypoalbuminemia	Metabolism and nutrition disorders	—	—
Hypocalcemia	Metabolism and nutrition disorders	—	—
Insomnia	Psychiatric disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Infections and Infestations, Other	Infections and infestations	—	—
Investigations - Other	Investigations	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—
Urinary tract Infection	Infections and infestations	—	—
Vomiting	Gastrointestinal disorders	—	—
Skin infection	Infections and infestations	—	—

Most-reported serious reactions: Soft tissue infection, Bone infection, Urinary tract Infection, Headache, Hypercalcemia, Acute kidney injury, Atrial fibrillation, Pericardial tamponade.

Data from ClinicalTrials.gov NCT03063632 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Roles of IFN-γ in tumor progression and regression: a review.
Jorgovanovic D, Song M, Wang L, Zhang Y. · · 2020 · cited 973× · PMID 33005420 · DOI 10.1186/s40364-020-00228-x
Genomic correlates of response to immune checkpoint blockade.
Keenan TE, Burke KP, Van Allen EM. · · 2019 · cited 367× · PMID 30842677 · DOI 10.1038/s41591-019-0382-x
Interferon gamma in cancer immunotherapy.
Ni L, Lu J. · · 2018 · cited 274× · PMID 30039553 · DOI 10.1002/cam4.1700
Systemic Interferon-γ Increases MHC Class I Expression and T-cell Infiltration in Cold Tumors: Results of a Phase 0 Clinical Trial.
Zhang S, Kohli K, Black RG, Yao L, et al · · 2019 · cited 125× · PMID 31171504 · DOI 10.1158/2326-6066.cir-18-0940
Emerging strategies in targeting tumor-resident myeloid cells for cancer immunotherapy.
Wang Y, Johnson KCC, Gatti-Mays ME, Li Z. · · 2022 · cited 103× · PMID 36031601 · DOI 10.1186/s13045-022-01335-y
Improving Immunotherapy Efficacy in Soft-Tissue Sarcomas: A Biomarker Driven and Histotype Tailored Review.
Roulleaux Dugage M, Nassif EF, Italiano A, Bahleda R. · · 2021 · cited 73× · PMID 34925348 · DOI 10.3389/fimmu.2021.775761
Molecular Aspects and Future Perspectives of Cytokine-Based Anti-cancer Immunotherapy.
Chulpanova DS, Kitaeva KV, Green AR, Rizvanov AA, et al · · 2020 · cited 71× · PMID 32582698 · DOI 10.3389/fcell.2020.00402
Synovial sarcoma: characteristics, challenges, and evolving therapeutic strategies.
Blay JY, von Mehren M, Jones RL, Martin-Broto J, et al · · 2023 · cited 67× · PMID 37625194 · DOI 10.1016/j.esmoop.2023.101618

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03063632 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 25 October 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03063632.

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