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Trial record 3 of 6 for:    ONCOS-102

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02963831
Recruitment Status : Recruiting
First Posted : November 15, 2016
Last Update Posted : October 22, 2020
Sponsor:
Collaborators:
Cancer Research Institute, New York City
MedImmune LLC
Targovax ASA
Information provided by (Responsible Party):
Ludwig Institute for Cancer Research

Tracking Information
First Submitted Date  ICMJE November 10, 2016
First Posted Date  ICMJE November 15, 2016
Last Update Posted Date October 22, 2020
Actual Study Start Date  ICMJE September 7, 2017
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2019)
Number of Adverse Events [ Time Frame: up to 15 months ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 10, 2016)
Number of Adverse Events [ Time Frame: up to 24 weeks ]
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2020)
  • Clinical Benefit (Complete Response, Partial Response and Stable Disease) for Cohorts 1 & 2 [ Time Frame: up to 24 weeks ]
    Clinical Benefit is defined as percentage of subjects who are in the study and not in progression at the end of Week 24.
  • Objective Response Rate for Cohorts 1 & 2 [ Time Frame: up to 15 months ]
  • Progression-free survival for Cohorts 1 & 2 [ Time Frame: Up to 15 months ]
  • Overall Survival for Cohorts 1 & 2 [ Time Frame: up to 4 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2016)
  • Clinical Benefit (CR, PR and SD) [ Time Frame: up to 24 weeks ]
  • Objective Response Rate [ Time Frame: a least 4 weeks ]
  • Progression-free survival [ Time Frame: up to 4 years ]
  • Overall Survival [ Time Frame: up to 4 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
Brief Summary This is a two-part Phase 1/2 dose escalation and dose expansion study of the 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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Colorectal Cancer
  • Platinum-resistant Ovarian Cancer
  • Appendiceal Cancer
Intervention  ICMJE
  • Biological: ONCOS-102
    ONCOS-102 will be administered intraperitoneally 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 Name: MEDI4736
Study Arms  ICMJE
  • 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 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.

    Interventions:
    • Biological: ONCOS-102
    • Drug: Durvalumab
  • 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.
    Interventions:
    • Biological: ONCOS-102
    • Drug: Durvalumab
  • 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.
    Interventions:
    • Biological: ONCOS-102
    • Drug: Durvalumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 10, 2016)
78
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2022
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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. Subject is willing to undergo a core needle biopsy during screening and 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. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mary Macri 212-450-1515 clintrialinformation@licr.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02963831
Other Study ID Numbers  ICMJE LUD2015-008
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ludwig Institute for Cancer Research
Study Sponsor  ICMJE Ludwig Institute for Cancer Research
Collaborators  ICMJE
  • Cancer Research Institute, New York City
  • MedImmune LLC
  • Targovax ASA
Investigators  ICMJE Not Provided
PRS Account Ludwig Institute for Cancer Research
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP