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History of Changes for Study: NCT02963831
A Phase 1/2 Study to Investigate the Safety, Biologic and Anti-tumor Activity of ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies
Latest version (submitted August 21, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 10, 2016 Nothing (earliest Version on record)
2 November 16, 2016 Outcome Measures and Study Status
3 January 19, 2017 Study Status and Conditions
4 September 7, 2017
Recruitment Status
, Study Status, Oversight, Contacts/Locations and Arms and Interventions
5 October 30, 2017 Study Status and Contacts/Locations
6 November 9, 2017 Study Status and Contacts/Locations
7 November 27, 2017 Contacts/Locations and Study Status
8 March 5, 2018 Study Status and Contacts/Locations
9 June 1, 2018 Study Status and Contacts/Locations
10 August 30, 2018 Study Status and Contacts/Locations
11 October 31, 2018 Study Status, Contacts/Locations, Eligibility and Conditions
12 December 20, 2018 Study Status and Contacts/Locations
13 January 10, 2019 Study Status and Contacts/Locations
14 March 14, 2019 Outcome Measures, Arms and Interventions, Study Status, Contacts/Locations, Eligibility and Study Description
15 August 21, 2019 Study Status and Contacts/Locations
Comparison Format:

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Changes (Merged) for Study: NCT02963831
January 10, 2019 (v13) -- March 14, 2019 (v14)

Changes in: Outcome Measures, Arms and Interventions, Study Status, Contacts/Locations, Eligibility and Study Description

Study Identification
Unique Protocol ID: LUD2015-008
Brief Title: A Phase 1/2 Study to Investigate the Safety, Biologic and Anti-tumor Activity of ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies
Official Title: A Phase 1/2 Dose Escalation Study With Expansion Cohorts to Investigate the Safety, Biologic and Anti-tumor Activity of ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies
Secondary IDs:
Study Status
Record Verification: January 2019 March 2019
Overall Status: Recruiting
Study Start: September 7, 2017
Primary Completion: July 2020 [Anticipated]
Study Completion: October 2022 [Anticipated]
First Submitted: November 10, 2016
First Submitted that
Met QC Criteria:
November 10, 2016
First Posted: November 15, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
January 10, 2019 March 14, 2019
Last Update Posted: January 11 March 18, 2019 [Actual]
Sponsor/Collaborators
Sponsor: Ludwig Institute for Cancer Research
Responsible Party: Sponsor
Collaborators: Cancer Research Institute, New York City
MedImmune LLC
Targovax ASA
Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Study Description
Brief Summary: This is a two-part Phase 1/2 dose escalation and dose expansion study of the GMCSFencoding GMCSF-encoding adenovirus, ONCOS-102, in combination with anti-programmed death ligand-1 (PDL1) antibody, durvalumab, in adult subjects with peritoneal disease who have failed prior standard chemotherapy and have histologically confirmed platinum-resistant or refractory epithelial ovarian cancer or colorectal cancer.
Detailed Description:
Conditions
Conditions: Colorectal Cancer
Platinum-resistant Ovarian Cancer
Appendiceal Cancer
Keywords: Oncos-102
Durvalumab
Peritoneal
Cyclophosphamide
Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1/Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 78 [Anticipated]
Arms and Interventions
Arms Assigned Interventions
Experimental: Dose Escalation

During Phase 1 of the study, subjects will be evaluated for DLTs before proceeding to a subsequent cohort. Dose escalation for the determination of RCD will be performed based on the available dose levels and the respective rules for a standard 3 + 3 dose escalation study design.

For Cohort A, ONCOS-102 (1 x 10^11 VP) will be given as monotherapy the first six weeks, and then durvalumab (1500 mg) will be starting on day 71.

For Cohorts B and C, ONCOS-102 will be administered for a total of 6 weeks while durvalumab will be given for a total of 12 four-week cycles.

Biological: ONCOS-102
ONCOS-102 will be administered intraperitoneally via a peritoneal Hickmann catheter (or institutionally preferred alternative) infusion at weekly intervals for 6 weeks.
Drug: Durvalumab
Durvalumab will be administered by IV infusion once every four weeks for a total of 12 four-week cycles.

Other Names:
  • MEDI4736
Experimental: Cohort 1: Platinum-resistant epithelial ovarian cancer
ONCOS-102 will be administered for a total of 6 weeks, while durvalumab will be administered for a total of 12 cycles, starting on Day 15.
Biological: ONCOS-102
ONCOS-102 will be administered intraperitoneally via a peritoneal Hickmann catheter (or institutionally preferred alternative) infusion at weekly intervals for 6 weeks.
Drug: Durvalumab
Durvalumab will be administered by IV infusion once every four weeks for a total of 12 four-week cycles.

Other Names:
  • MEDI4736
Experimental: Cohort 2: Colorectal cancer
ONCOS-102 will be administered for a total of 6 weeks, while durvalumab will be administered for a total of 12 cycles, starting on Day 15.
Biological: ONCOS-102
ONCOS-102 will be administered intraperitoneally via a peritoneal Hickmann catheter (or institutionally preferred alternative) infusion at weekly intervals for 6 weeks.
Drug: Durvalumab
Durvalumab will be administered by IV infusion once every four weeks for a total of 12 four-week cycles.

Other Names:
  • MEDI4736
Outcome Measures
Primary Outcome Measures:
1. Number of Adverse Events
Clinical laboratory tests, vital sign and weight measurements, physical exams, performance status evaluation, imaging scans and any other medically indicated assessments, including subject interviews, will be performed to detect new abnormalities and deteriorations of any pre-existing conditions. The investigator will evaluate any laboratory abnormalities for clinical significance, and clinically significant abnormalities will be recorded as adverse events. All clinically significant abnormalities and deteriorations from time of signing the informed consent to the end of study visit will be recorded in the Case Report Forms as adverse events and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03.

[Time Frame: up to 24 weeks up to 15 months]
Secondary Outcome Measures:
2. Clinical Benefit (Complete Response, Partial Response and Stable Disease)
Clinical Benefit is defined as percentage of subjects who are in the study and not in progression at the end of Week 24.

[Time Frame: up to 24 weeks]
3. Objective Response Rate
a least 4 weeks up to 15 months
4. Progression-free survival
up to 4 years Up to 15 months
5. Overall Survival
up to 4 years
Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. Subjects with peritoneal disease who have failed prior standard chemotherapy and have histologic confirmation of epithelial ovarian cancer or metastatic colorectal cancer (CRC) including cancer originating from the appendix.
  2. The Subject is willing to undergo a core needle biopsy during screening and during Cycle 2, Study Week 5. Archival tumor samples are requested, but are not required for eligibility.
  3. Previously treated for advanced cancer with no additional therapy options available known to prolong survival.
  4. Laboratory parameters for vital functions should be in the normal range or not clinically significant.
  5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

Exclusion Criteria:

  1. Treatment with an investigational agent within 4 weeks of starting study treatment or prior treatment with a checkpoint inhibitor (cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), programmed cell death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) antibodies).
  2. Subjects with known active central nervous system metastasis, glioma and nervous system malignancies including carcinomatous meningitis or other invasive malignancy within 5 years except for noninvasive malignancies such as cervical carcinoma in situ, non-melanomatous carcinoma of the skin or ductal carcinoma in situ of the breast that has/have been surgically cured. Subject has known active central nervous system metastasis, glioma and nervous system malignancies including carcinomatous meningitis. Subjects with asymptomatic brain metastases or spinal cord compression who have been treated, are considered stable, and who have not received corticosteroids or anticonvulsants for at least 28 days prior to screening may be included. Subject has other active malignancy.
  3. Known immunodeficiency or known to have evidence of acute or chronic or human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C or other uncontrolled inter-current illnesses.
  4. Ongoing bowel perforation or presence of bowel fistula or abscess or history of small or large bowel obstruction within 3 months of registration, including subjects with palliative gastric drainage catheters. Subjects with palliative diverting ileostomy or colostomy are allowed if they have been symptom-free for more than 3 months.
  5. Subjects with clinically significant cardiovascular disease, history of organ transplant or allogeneic bone marrow transplant, active known or history of autoimmune disease that might recur or major surgery within 28 days prior to the first dose or still recovering from prior surgery.
Contacts/Locations
Central Contact: Lisa Shohara
Telephone: 212-450-1515
Email: clintrialinformation@licr.org
Central Contact Backup: Danielle McCabe
Telephone: 212-450-1515
Email: clintrialinformation@licr.org
Locations: United States, Florida
Research Facility
[Recruiting]
Miami, Florida, United States, 33136
United States, New York
Research Facility
[Recruiting]
Buffalo, New York, United States, 14263
Research Facility
[Recruiting]
New York, New York, United States, 10065
United States, Ohio
Research Facility
[Recruiting]
Toledo, Ohio, United States, 43614
United States, Virginia
Research Facility
[Recruiting]
Charlottesville, Virginia, United States, 22903
IPDSharing
Plan to Share IPD:
References
Citations:
Links:
Available IPD/Information:

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