ClinicalTrials.gov

History of Changes for Study: NCT03092323
A Randomized Trial of Pembrolizumab & Radiotherapy Versus Radiotherapy in High-Risk Soft Tissue Sarcoma of the Extremity (SU2C-SARC032)
Latest version (submitted March 25, 2022) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 March 20, 2017 None (earliest Version on record)
2 June 21, 2017 Study Status
3 July 11, 2017 Study Status and Eligibility
4 July 19, 2017 Recruitment Status, Study Status, Contacts/Locations and Oversight
5 September 21, 2017 Study Status and Contacts/Locations
6 October 10, 2017 Contacts/Locations, Oversight and Study Status
7 October 25, 2017 Study Status and Contacts/Locations
8 December 15, 2017 Contacts/Locations and Study Status
9 January 26, 2018 Recruitment Status, Contacts/Locations and Study Status
10 February 12, 2018 Contacts/Locations and Study Status
11 March 16, 2018 Recruitment Status, Contacts/Locations, Eligibility and Study Status
12 June 26, 2018 Contacts/Locations and Study Status
13 September 26, 2018 Contacts/Locations and Study Status
14 November 8, 2018 Study Status and Contacts/Locations
15 February 27, 2019 Contacts/Locations and Study Status
16 March 28, 2019 Contacts/Locations and Study Status
17 January 17, 2020 Study Status, Contacts/Locations, Eligibility, Outcome Measures and Study Design
18 July 1, 2021 Study Status
19 March 25, 2022 Study Status, Contacts/Locations and Study Design
Comparison Format:

Scroll up to access the controls

Study NCT03092323
Submitted Date:  March 20, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: SU2C-SARC032
Brief Title: A Randomized Trial of Pembrolizumab & Radiotherapy Versus Radiotherapy in High-Risk Soft Tissue Sarcoma of the Extremity (SU2C-SARC032)
Official Title: SU2C-SARC032: A Phase II Randomized Controlled Trial of Neoadjuvant Pembrolizumab With Radiotherapy and Adjuvant Pembrolizumab in Patients With High-Risk, Localized Soft Tissue Sarcoma of the Extremity
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2017
Overall Status: Not yet recruiting
Study Start: May 1, 2017
Primary Completion: May 1, 2024 [Anticipated]
Study Completion: May 30, 2025 [Anticipated]
First Submitted: March 15, 2017
First Submitted that
Met QC Criteria:
March 20, 2017
First Posted: March 27, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
March 20, 2017
Last Update Posted: March 27, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Sarcoma Alliance for Research through Collaboration
Responsible Party: Sponsor
Collaborators: Stand Up To Cancer
Merck Sharp & Dohme LLC
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: This is an open-label, multi-institutional phase II randomized study comparing neoadjuvant radiotherapy followed by surgical resection to neoadjuvant pembrolizumab with concurrent radiotherapy, followed by surgical resection and adjuvant pembrolizumab. The total duration of pembrolizumab will be one year in the experimental arm.
Detailed Description: This is a multicenter, randomized phase II trial with an initial safety run-in to test the safety and efficacy of neoadjuvant pembrolizumab with image-guided radiotherapy and adjuvant pembrolizumab compared to radiation therapy alone in patients with clinically localized extremity soft tissue sarcoma at high risk for developing metastatic disease (tumor size > 5 cm, intermediate- to high-grade; approximately 50% risk for distant disease at 2 years). Histologies will be limited to undifferentiated pleomorphic sarcoma and dedifferentiated/pleomorphic liposarcoma based on preliminary data from SARC028. Other terms for undifferentiated pleomorphic sarcoma may include, but are not limited to. pleomorphic undifferentiated sarcoma, unclassified spindle cell sarcoma, spindle cell sarcoma not otherwise specified, pleomorphic spindle cell sarcoma, pleomorphic fibroblastic sarcoma, undifferentiated high-grade pleomorphic sarcoma, pleomorphicsarcoma with prominent inflammation, pleomorphic sarcoma with giant cells, malignant fibrous histiocytoma (including storiform-pleomorphic and inflammatory subtypes), fibrosarcoma, and myxofibrosarcoma (located deep to the fascia in muscle). Radiation therapy with three cycles of pembrolizumab will be administered as neoadjuvant therapy for patients randomized to the experimental arm. These patients will also receive up to fourteen cycles of adjuvant pembrolizumab after surgical resection. Patients in the standard of care arm will receive neoadjuvant radiotherapy (50 Gy in 25 fractions) followed by surgical resection as in RTOG 0630.
Open or close this module Conditions
Conditions: Soft Tissue Sarcoma of the Extremity
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 110 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Treatment
Neoadjuvant pembrolizumab with concurrent radiotherapy, followed by surgical resection and adjuvant pembrolizumab.
Drug: Pembrolizumab
Pembrolizumab will be administered at 200 mg intravenously every 3 weeks for patients on the treatment arm.
Other Names:
  • KEYTRUDA®
No Intervention: Standard of Care
Neoadjuvant radiotherapy followed by surgical resection.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Disease free survival
[ Time Frame: 2 Years ]

Disease recurrence is defined as clinically diagnosed or biopsy-confirmed recurrent sarcoma at a site distant to the primary tumor, including nodal metastasis, loco-regional recurrence, and death without documented recurrence.
Secondary Outcome Measures:
1. Loco-regional disease-free survival
[ Time Frame: 5 years ]

The length of time after treatment ends without any locoregional recurrence of sarcoma.
2. Distant disease free survival
[ Time Frame: 5 years ]

The length of time after treatment ends that the patient survives without any signs or symptoms of sarcoma
3. Overall survival
[ Time Frame: 5 years ]

The length of time from the start of treatment that patients diagnosed with sarcoma are still alive.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Age ≥ 18 years
  • Histologically confirmed diagnosis of grade 2 or 3 out of 3 UPS or dedifferentiated/pleomorphic LPS of the extremity (including limb girdle, i.e. shoulder or hip) that measures greater than 5 cm in any direction as assessed by imaging; Alternative terms for UPS meeting inclusion criteria include but are not limited to the following
  • Patients with non-melanomatous skin cancer, in situ carcinoma, or low-risk prostate cancer can be enrolled.
  • ECOG Performance Status of 0 or 1 (see Appendix A)
  • Resectable primary tumor with no evidence of metastatic disease by imaging. Imaging must be performed within 45 days of Day 1 of study.
  • Adequate organ function within 10 days of Day 1 of study defined as:
  • Written, voluntary informed consent
  • Fertile men and women of childbearing potential must agree to use an effective method of birth control from Day 1 of study and for 120 days after last pembrolizumab administration in both sexes. Women of childbearing potential include pre-menopausal women and women within the first 2 years of the onset of menopause. Women of childbearing potential must have a negative pregnancy test ≤ 72 hours prior to Day 1 of study.

Exclusion Criteria:

  • Prior chemotherapy, targeted small molecule therapy, or radiation therapy for current diagnosis of sarcoma
  • Prior radiation therapy in excess of 20 Gy to the site of the current diagnosis of sarcoma. No overlap with prior radiation fields in excess of 20 Gy is allowed.
  • Concurrent, clinically significant, active malignancies within two years of study enrollment.
  • Patients with locally recurrent sarcoma after surgery alone are eligible for enrollment if other inclusion criteria are met.
  • Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol
  • Major surgery within three months prior to Day 1 of study or who have not recovered adequately from prior surgery.
  • Currently receiving a study therapy or if they had an investigational agent within 4 weeks at the time of enrollment.
  • Women who are pregnant or nursing/breastfeeding, or expecting to conceive or men who are expecting to father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of pembrolizumab.
  • Inability to comply with protocol required procedures
  • Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy by oral or IV routes within 7 days prior to the first dose of trial treatment
  • Known history of active TB (Bacillus Tuberculosis)
  • Hypersensitivity to pembrolizumab or any of its excipients
  • Metastatic disease or regional lymph node involvement. Chest CT will be mandatory prior to enrollment to evaluate for the presence of metastatic disease. Pulmonary nodule(s) < 5 mm without a histological diagnosis may not be the basis for study exclusion given the lack of specificity of chest CT. If pulmonary nodule(s) > 5 mm are noted on chest CT but appear stable relative to prior chest imaging of at least 6 months duration, then this is permitted.
  • Unresectable disease or medically inoperable
  • Planned to receive neoadjuvant or adjuvant chemotherapy for current diagnosis of localized soft tissue sarcoma
  • Active autoimmune disease that has required systemic treatment in the past two years (i.e. with use of disease modifying agents, systemic corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • Has a history of (non-infectious) pneumonitis that required systemic steroids or current pneumonitis.
  • Active infection requiring systemic therapy
  • Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
  • Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
  • Known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)
  • Known active Hepatitis B (e.g., HBsAg reactive, confirmed by detectable viral load) or Hepatitis C (e.g., HCV RNA [qualitative] detected)
  • Received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
  • Diagnosis of scleroderma.
  • Diagnosis of inflammatory bowel disease (Crohn's disease or Ulcerative Colitis).
Open or close this module Contacts/Locations
Central Contact Person: SARC Trials
Telephone: 734-930-7600
Email: SARC@sarctrials.org
Study Officials: David Kirsch, MD, PhD
Principal Investigator
Duke University
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services