Study of Tremelimumab Alone or Combined With Olaparib for Patients With Persistent EOC (Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma)

NCT ID: NCT02485990

Last Updated: 2021-04-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-08
• Study Completion Date: 2020-03-05

Brief Summary

This study will be looking at what dose of tremelimumab and olaparib is safe and effective in patients with persistent EOC (Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma).

Detailed Description

This clinical trial was initially intended to be a Phase 1/2 trial, but the trial never moved forward to Phase 2 prior to termination.

Conditions

Primary Peritoneal Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A: Tremelimumab Alone

25 patients will receive tremelimumab alone at 10 mg/kg IV every 4 weeks for 7 doses then every 12 weeks until disease progression.

Group Type: EXPERIMENTAL

Tremelimumab

Intervention Type: DRUG

Arm B1: DESE Tremelimumab and Olaparib

18 patients will receive tremelimumab (3 or 10 mg/kg IV) every 4 weeks for 7 doses then every 12 weeks and olaparib (150 or 300 mg orally twice a day) until disease progression.

Group Type: EXPERIMENTAL

Tremelimumab

Intervention Type: DRUG

Olaparib

Intervention Type: DRUG

Arm B2: Tremelimumab and Olaparib

25 patients will receive tremelimumab (every 4 weeks for 7 doses then every 12 weeks) and olaparib (daily) until disease progression. Dose of tremelimumab and olaparib will be determined during the DESE (Arm B1).

Group Type: EXPERIMENTAL

Tremelimumab

Intervention Type: DRUG

Olaparib

Intervention Type: DRUG

Interventions

Tremelimumab

Intervention Type: DRUG

Olaparib

Intervention Type: DRUG

Other Intervention Names

LYNPARZA

Eligibility Criteria

Inclusion Criteria

1. Signed informed consent form

2. Age ≥ 18 years

3. Recurrent or persistent EOC (epithelial ovarian, fallopian tube or primary peritoneal carcinoma)

4. Have archival tissue or willingness to undergo a tumor biopsy

5. Have measurable disease

6. Have had one prior taxane-platinum-based chemotherapeutic regimen

7. Have had a treatment-free interval following platinum-based therapy of less than 12 months, have progressed during platinum-based therapy, or had persistent disease after a platinum-based regimen

8. Have received hormonal therapy

9. ECOG Performance Status of 0 to 1

10. Ability to take oral medications

11. HIV, HTLV-1, HBV, and HCV negative

12. Adequate organ and bone marrow function as defined by study-specified laboratory tests

13. Normal blood coagulation parameters

14. Life expectancy greater than 16 weeks

15. Must use acceptable form of birth control through the study and for 28 days after final dose of study drug

16. Willing and able to comply with study procedures

Exclusion Criteria

1. Prior therapy with an anti-CTLA-4 antibody or PARP inhibitor

2. Active infection requiring antibiotics

3. Active autoimmune disease

4. Active and uncontrolled intercurrent illness

5. History of other cancers within the past 5 years

6. Systemically active steroid use

7. Receiving systemic chemotherapy or radiotherapy within 4 weeks prior to the first dose of study drug

8. Use of ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir

9. Requirement for chronic parenteral hydration/nutrition

10. Vaccination with live attenuated vaccine within 1 month prior to first dose of study drug

11. Patients with untreated brain metastases, treated brain metastases that are not stable, leptomeningeal disease, or seizures uncontrolled with standard medical therapy

12. Patients with myelodysplastic syndrome/acute myeloid leukaemia

13. History of diverticulitis

14. History of bleeding disorder or diathesis.

15. Serious or nonhealing wound, ulcer, bone fracture, or osteonecrosis of the jaw

16. Major surgical procedure within 28 days of study enrollment, or anticipated while on study.

17. Pregnant or breast feeding woman

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

MedImmune LLC

INDUSTRY

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephanie Gaillard, MD

Role: PRINCIPAL_INVESTIGATOR

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Locations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

IRB00064379

Identifier Type: OTHER

Identifier Source: secondary_id

J15113

Identifier Type: -

Identifier Source: org_study_id