Primary Peritoneal CarcinomaPhase 1NCT02485990
Study of Tremelimumab Alone or Combined With Olaparib for Patients With Persistent EOC (Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma)
A Phase 1 study testing Tremelimumab and Olaparib in people with Primary Peritoneal Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Peritoneal Carcinoma
- What is being tested?
- Tremelimumab and Olaparib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2016to 5 Mar 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent form
- Age ≥ 18 years
- Recurrent or persistent EOC (epithelial ovarian, fallopian tube or primary peritoneal carcinoma)
- Have archival tissue or willingness to undergo a tumor biopsy
- Have measurable disease
- Have had one prior taxane-platinum-based chemotherapeutic regimen
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- 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
- Have received hormonal therapy
- ECOG Performance Status of 0 to 1
- Ability to take oral medications
- HIV, HTLV-1, HBV, and HCV negative
- Adequate organ and bone marrow function as defined by study-specified laboratory tests
- Normal blood coagulation parameters
- Life expectancy greater than 16 weeks
- Must use acceptable form of birth control through the study and for 28 days after final dose of study drug
- Willing and able to comply with study procedures
Who cannot join
- Prior therapy with an anti-CTLA-4 antibody or PARP inhibitor
- Active infection requiring antibiotics
- Active autoimmune disease
- Active and uncontrolled intercurrent illness
- History of other cancers within the past 5 years
- Systemically active steroid use
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- Receiving systemic chemotherapy or radiotherapy within 4 weeks prior to the first dose of study drug
- Use of ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir
- Requirement for chronic parenteral hydration/nutrition
- Vaccination with live attenuated vaccine within 1 month prior to first dose of study drug
- Patients with untreated brain metastases, treated brain metastases that are not stable, leptomeningeal disease, or seizures uncontrolled with standard medical therapy
- Patients with myelodysplastic syndrome/acute myeloid leukaemia
- History of diverticulitis
- History of bleeding disorder or diathesis.
- Serious or nonhealing wound, ulcer, bone fracture, or osteonecrosis of the jaw
- Major surgical procedure within 28 days of study enrollment, or anticipated while on study.
- Pregnant or breast feeding woman
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231
About this study
Official title: An Open Label Dose Escalation/Expansion Study of Tremelimumab Alone or Combined With Olaparib for Recurrent or Persistent EOC (Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma)
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).
Read the 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
- Being tested
- Tremelimumab, Olaparib
- Keywords
- Fallopian Tube, Epithelial Ovarian, EOC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TremelimumabDrug
OlaparibDrug
Also called LYNPARZA
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Tremelimumab Alone | Experimental | 25 patients will receive tremelimumab alone at 10 mg/kg IV every 4 weeks for 7 doses then every 12 weeks until disease progression. Receives: Drug: Tremelimumab |
| Arm B1: DESE Tremelimumab and Olaparib | Experimental | 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. Receives: Drug: Tremelimumab; Drug: Olaparib |
| Arm B2: Tremelimumab and Olaparib | Experimental | 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). Receives: Drug: Tremelimumab; Drug: Olaparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events as a measure of the safety and tolerability profile of tremelimumab in combination with olaparib
Number of participants experiencing study drug-related dose limiting toxicities (DLTs). Dose escalation (phase I) portion of the trial only.
Measured: 4 years
Fold change from baseline in the ratio of peripheral CD4+ICOShi T cells and Regulatory T cells
Dose escalation (phase I) portion of the trial only.
Measured: 4 years
Maximum Tolerated Dose (MTD) of tremelimumab combined with olaparib
Dose escalation (phase I) portion of the trial only.
Measured: 4 years
Secondary outcomes (9)
Progression Free Survival (PFS) Rate at 6 months by RECIST
PFS rate is defined as the percentage of patients with disease progression (PD or relapse from CR as assessed using RECIST 1.1 criteria) or death due to any cause at 6 months. Per RECIST 1.1 criteria, Complete Response (CR) = disappearance of all target lesions, Partial Response (PR) is =>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is >20% increase in sum of diameters of target lesions, Stable Disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve.
Measured: 6 months
Progression Free Survival (PFS) Rate at 6 months by irRECIST
PFS rate is defined as the percentage of patients with disease progression (irPD or relapse from irCR as assessed using irRECIST criteria) or death due to any cause at 6 months. Per irRECIST criteria, irCR = disappearance of all lesions, irPR is =>30% decrease in tumor burden, irPD is >20% increase in tumor burden compared with nadir, irSD is <30% decrease in tumor burden compared with baseline cannot be established nor <20% increase compared with nadir. Estimation based on the Kaplan-Meier curve.
Measured: 6 months
Objective Response Rate (ORR) by RECIST
Objective Response Rate (ORR) is defined as the percentage of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. Per RECIST 1.1 criteria, CR = disappearance of all target lesions and PR is =>30% decrease in sum of diameters of target lesions.
Measured: 4 years
Objective Response Rate (ORR) by irRECIST
Objective Response Rate (irORR) is defined as the percentage of patients achieving a complete response (irCR) or partial response (irPR) based on irRECIST criteria. Per irRECIST criteria, irCR = disappearance of all lesions and irPR is =>30% decrease in tumor burden.
Measured: 4 years
Duration of Response by RECIST
Number of months from the start date of PR or CR (whichever response is recorded first) and subsequently confirmed to the first date that recurrent or progressive disease or death is documented. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, and PD is >20% increase in sum of diameters of target lesions.
Measured: 4 years
Duration of Response by irRECIST
Number of months from the start date of irPR or irCR (whichever response is recorded first) and subsequently confirmed to the first date that recurrent or progressive disease or death is documented. Per irRECIST criteria, irCR = disappearance of all lesions, irPR is =>30% decrease in tumor burden, and irPD is is >20% increase in tumor burden compared with nadir.
Measured: 4 years
Disease Control Rate (DCR)
DCR is defined as the number of patients achieving a complete response (CR) or partial response (PR) or stable disease (SD) based on RECIST 1.1 criteria at any time during the study. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, PD is >20% increase in sum of diameters of target lesions, SD is <30% decrease or <20% increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve.
Measured: 4 years
Progression-Free Survival (PFS)
PFS is defined as the number of patients with disease progression (progressive disease [PD] or relapse from complete response [CR] as assessed using RECIST 1.1 criteria) or death due to any cause. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is >20% increase in sum of diameters of target lesions, Stable Disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve.
Measured: 4 years
Overall Survival (OS)
OS will be measured from date of first dose until death or end of followup (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study start8 Jan 2016
- Primary completion5 Mar 2020
- Study completion5 Mar 2020
Why it stopped: Withdrawal of sponsor support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Peritoneal CarcinomaStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, MedImmune LLC
- Responsible party
- Sponsor
- Investigators
- Stephanie Gaillard, MD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02485990
- Sponsor's protocol ID
- J15113
- Other IDs
- IRB00064379
- Status last verified
- Apr 2021
- First submitted
- 26 Jun 2015
- Last updated
- 12 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Dose Escalation/Expansion Study of Tremelimumab Alone or Combined With Olaparib for Recurrent or Persistent EOC (Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma)
- ClinicalTrials.gov ID
- NCT02485990
- Acronym / sponsor ID
- J15113
- Conditions
- Primary Peritoneal Carcinoma
- Keywords
- Fallopian Tube, Epithelial Ovarian, EOC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Withdrawal of sponsor support
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- AstraZeneca, MedImmune LLC
- Study start
- 8 Jan 2016 (actual)
- Primary completion
- 5 Mar 2020 (actual)
- Study completion
- 5 Mar 2020 (actual)
- First posted
- 30 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A: Tremelimumab Alone | Experimental | Drug: Tremelimumab25 patients will receive tremelimumab alone at 10 mg/kg IV every 4 weeks for 7 doses then every 12 weeks until disease progression. |
| Arm B1: DESE Tremelimumab and Olaparib | Experimental | Drug: Tremelimumab, Drug: Olaparib18 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. |
| Arm B2: Tremelimumab and Olaparib | Experimental | Drug: Tremelimumab, Drug: Olaparib25 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Signed informed consent form
- Age ≥ 18 years
- Recurrent or persistent EOC (epithelial ovarian, fallopian tube or primary peritoneal carcinoma)
- Have archival tissue or willingness to undergo a tumor biopsy
- Have measurable disease
Key exclusion criteria (17 listed)
- Prior therapy with an anti-CTLA-4 antibody or PARP inhibitor
- Active infection requiring antibiotics
- Active autoimmune disease
- Active and uncontrolled intercurrent illness
- History of other cancers within the past 5 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tremelimumab | Drug | Arm A: Tremelimumab Alone, Arm B1: DESE Tremelimumab and Olaparib, Arm B2: Tremelimumab and Olaparib |
| OlaparibAlso: LYNPARZA | Drug | Arm B1: DESE Tremelimumab and Olaparib, Arm B2: Tremelimumab and Olaparib |
Primary outcome
Adverse events as a measure of the safety and tolerability profile of tremelimumab in combination with olaparib
Time frame: 4 years
Number of participants experiencing study drug-related dose limiting toxicities (DLTs). Dose escalation (phase I) portion of the trial only.
Fold change from baseline in the ratio of peripheral CD4+ICOShi T cells and Regulatory T cells
Time frame: 4 years
Dose escalation (phase I) portion of the trial only.
Maximum Tolerated Dose (MTD) of tremelimumab combined with olaparib
Time frame: 4 years
Dose escalation (phase I) portion of the trial only.
9 secondary outcomes
Progression Free Survival (PFS) Rate at 6 months by RECIST
Time frame: 6 months
Progression Free Survival (PFS) Rate at 6 months by irRECIST
Time frame: 6 months
Objective Response Rate (ORR) by RECIST
Time frame: 4 years
Objective Response Rate (ORR) by irRECIST
Time frame: 4 years
Duration of Response by RECIST
Time frame: 4 years
Duration of Response by irRECIST
Time frame: 4 years
Disease Control Rate (DCR)
Time frame: 4 years
Progression-Free Survival (PFS)
Time frame: 4 years
Overall Survival (OS)
Time frame: 4 years
Results and safety
The study was stopped early (reason given: Withdrawal of sponsor support). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Gaillard, MD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tremelimumab and Olaparib in people with Primary Peritoneal Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Withdrawal of sponsor support). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events as a measure of the safety and tolerability profile of tremelimumab in combination with olaparib (time frame: 4 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2021.