Trial · NCT03063632
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
NCT03063632, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2022-08-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT03063632. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03063632
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT03063632
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 28 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
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
- Interventions
- Interferon Gamma-1b, Laboratory Biomarker Analysis, Pembrolizumab
- First posted
- 2017-02-24
- Last updated
- 2023-10-25
- Results first posted
- 2022-08-30
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) | 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 (CR) disappearance of all lesions and no new lesion; Partial Response (PR), 30% or greater reduction in tumor size and no new lesions. The ORR is defined as CR combined with PR. Will be assessed using binomial proportion. Best response at any timepoint was used to determine ORR. |
| Secondary | Incidence of Adverse Events | Up to 2 years and 1 months | Will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. |
| Secondary | Time to Response (TTR) | 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. |
| Secondary | Duration of Response (DOR) | 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. |
| Secondary | Progression-free Survival (PFS) | 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 |
| Secondary | Event-free Survival (EFS) | 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. |
| Secondary | Rate of Overall Response Duration Beyond 12 Months (ORR12) | 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. |
| Other | Biomarkers in Tumor and Blood Assessed by Immunohistochemistry, Mass Spectrometry, Nanostring, Sequencing, and Enzyme-linked Immunosorbent Assay | Up to 3 years | Clinical response (as measured by the primary and secondary endpoints) to combination immunotherapy regimen as a function of biomarkers will be evaluated. All biomarker assays will be run on the clinical trial samples in a blinded manner. Time to event endpoints (DOR, PFS, EFS) will be evaluated using Kaplan-Meier curves generated by biomarker scoring group using the log-rank test. Exploratory outcomes will be summarized with descriptive statistics (primarily proportions and medians) for all biomarkers described above, and additionally, serum IL-10, regulatory T-cells, and activated CD8 T cells. Scatterplots and Kendall's tau estimates will be produced for estimating correlation of PD-1, PDL1, or PD-L2 expression measures and clinical outcome across compartments (skin, lymph node, blood). Comparison of tissue immunohistochemistry markers between pre-treatment and with clinical response or disease progression will be assessed using Wilcoxon signed-rank test. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (ORR) | Up to 2 years | Both Treatment Group 1 and Treatment Group 2 study participants received at least one dose of IV pembrolizumab on study, and 27 participants received at least one dose of Interferon gamma on study. While not all participants reached the first disease assessment timepoint specified in the protocol, all had documented disease status at the time of treatment or study discontinuation. Therefore, no study participants were excluded from ORR analysis due to missing data. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence of Adverse Events | Up to 2 years and 1 months | All treated subjects. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Response (TTR) | Time interval between the date of first treatment and the date of response (complete response [CR]/partial response [PR]), up to 2 years | Non-responders are excluded in the analysis. | days | MEDIAN |
| SECONDARY | Duration of Response (DOR) | Time interval between the date of first response (CR/PR) and the date of progression, up to 2 years and 11 months | Non-responders are excluded in analysis; censored at last follow-up or start of new significant therapy | days | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) | Time from enrollment to disease progression or death, whichever occurs earlier, based upon investigator assessment, up to 3 years | All efficacy or safety evaluable patients. Censored at last follow-up or start of new significant therapy. | days | MEDIAN |
| SECONDARY | Event-free Survival (EFS) | Termination due to toxicity, initiation of next significant treatment, progressive disease, or death of any cause, up to 2 years | All efficacy or safety evaluable patients. Event is defined by early termination due to toxicity, start of new significant therapy, PD, or death of any cause. | days | MEDIAN |
| SECONDARY | Rate of Overall Response Duration Beyond 12 Months (ORR12) | 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 | Evaluable duration of response beyond 12 months for evaluable population. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Biomarkers in Tumor and Blood Assessed by Immunohistochemistry, Mass Spectrometry, Nanostring, Sequencing, and Enzyme-linked Immunosorbent Assay | Up to 3 years |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (ORR) | Group I (Pembrolizumab, Interferon Gamma-1b) | 6 | Participants | ||
| Overall Response Rate (ORR) | Group II (Pembrolizumab, Interferon Gamma-1b) | 0 | Participants | ||
| Incidence of Adverse Events | Group I (Pembrolizumab, Interferon Gamma-1b) | 15 | Participants | ||
| Incidence of Adverse Events | Group II (Pembrolizumab, Interferon Gamma-1b) | 12 | Participants | ||
| Time to Response (TTR) | Group I (Pembrolizumab, Interferon Gamma-1b) | 126 | Inter-Quartile Range 106 to 463 | days | |
| Duration of Response (DOR) | Group I (Pembrolizumab, Interferon Gamma-1b) | 505.0 | 95% Confidence Interval 106.0 to NA | days | |
| Progression-free Survival (PFS) | Group I (Pembrolizumab, Interferon Gamma-1b) | 394.0 | 95% Confidence Interval 120.0 to 615.0 | days | |
| Progression-free Survival (PFS) | Group II (Pembrolizumab, Interferon Gamma-1b) | 196.5 | 95% Confidence Interval 32.0 to NA | days | |
| Event-free Survival (EFS) | Group I (Pembrolizumab, Interferon Gamma-1b) | 185.5 | 95% Confidence Interval 120.0 to 394.0 | days | |
| Event-free Survival (EFS) | Group II (Pembrolizumab, Interferon Gamma-1b) | 73.0 | 95% Confidence Interval 32.0 to NA | days |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group I (Pembrolizumab, Interferon Gamma-1b) | 16 | |
| Overall Study | STARTED | Group II (Pembrolizumab, Interferon Gamma-1b) | 12 | |
| Overall Study | COMPLETED | Group I (Pembrolizumab, Interferon Gamma-1b) | 9 | |
| Overall Study | COMPLETED | Group II (Pembrolizumab, Interferon Gamma-1b) | 2 | |
| Overall Study | NOT COMPLETED | Group I (Pembrolizumab, Interferon Gamma-1b) | 7 | |
| Overall Study | NOT COMPLETED | Group II (Pembrolizumab, Interferon Gamma-1b) | 10 |
Source ClinicalTrials.gov
Adverse events242
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Alanine aminotransferase increased | Investigations | Group I (Pembrolizumab, Interferon Gamma-1b) | 1 | 16 | 1 |
| other | Alanine aminotransferase increased | Investigations | Group II (Pembrolizumab, Interferon Gamma-1b) | 1 | 12 | 1 |
| other | Alkaline phosphatase increased | Investigations | Group I (Pembrolizumab, Interferon Gamma-1b) | 1 | 16 | 2 |
| other | Alkaline phosphatase increased | Investigations | Group II (Pembrolizumab, Interferon Gamma-1b) | 1 | 12 | 1 |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Group I (Pembrolizumab, Interferon Gamma-1b) | 0 | 16 | 0 |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Group II (Pembrolizumab, Interferon Gamma-1b) | 1 | 12 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Group I (Pembrolizumab, Interferon Gamma-1b) | 1 | 16 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Group II (Pembrolizumab, Interferon Gamma-1b) | 8 | 12 | 22 |
| other | Anorexia | Metabolism and nutrition disorders | Group I (Pembrolizumab, Interferon Gamma-1b) | 1 | 16 | 1 |
| other | Anorexia | Metabolism and nutrition disorders | Group II (Pembrolizumab, Interferon Gamma-1b) | 2 | 12 | 2 |
1 to 10 of 242Source ClinicalTrials.gov
See all 242 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group I (Pembrolizumab, Interferon Gamma-1b) | 4 | 16 |
| Total, all-cause mortality | Group II (Pembrolizumab, Interferon Gamma-1b) | 6 | 12 |
| Total, other adverse events | Group I (Pembrolizumab, Interferon Gamma-1b) | 15 | 16 |
| Total, other adverse events | Group II (Pembrolizumab, Interferon Gamma-1b) | 12 | 12 |
| Total, serious adverse events | Group I (Pembrolizumab, Interferon Gamma-1b) | 4 | 16 |
| Total, serious adverse events | Group II (Pembrolizumab, Interferon Gamma-1b) | 5 | 12 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32269142 | DERIVED |
Source PubMed
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| P30CA015704 | Cancer Center Support Grant | LYNCH, THOMAS JAMES | FRED HUTCHINSON CANCER CENTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 | NIH RePORTER |
| U01CA154967 | Cancer Immunotherapy Trials Network Central Operations and Statistical Center | CHEEVER, MARTIN ALEXANDER | FRED HUTCHINSON CANCER RESEARCH CENTER | NATIONAL CANCER INSTITUTE | 2010 to 2017 | NIH RePORTER |
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Group I (Pembrolizumab, Interferon Gamma-1b) vs Group II (Pembrolizumab, Interferon Gamma-1b): Overall Response Rate (ORR) | Trial comparisons |
| Group I (Pembrolizumab, Interferon Gamma-1b) vs Group II (Pembrolizumab, Interferon Gamma-1b): Incidence of Adverse Events | Trial comparisons |
| Group I (Pembrolizumab, Interferon Gamma-1b) vs Group II (Pembrolizumab, Interferon Gamma-1b): deaths from any cause | Trial comparisons |
| Group I (Pembrolizumab, Interferon Gamma-1b) vs Group II (Pembrolizumab, Interferon Gamma-1b): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
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