New drug combo shows promise for recurrent ovarian cancer
NCT ID NCT04034927
First seen Jun 25, 2026 · Last updated Aug 27, 2026 · Updated 4 times
Summary
This phase II trial tests whether adding the immunotherapy tremelimumab to the PARP inhibitor olaparib works better than olaparib alone for women with platinum-sensitive recurrent ovarian, fallopian tube, or peritoneal cancer. About 61 participants will receive either olaparib alone or olaparib plus tremelimumab. The study measures how long the cancer stays under control and any side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- olaparib and tremelimumab
- What this could lead to
- If successful, this combination could offer a more effective treatment option for women with recurrent ovarian cancer that responds to platinum-based therapy.
- What could go wrong
- This is a small, early-phase trial (61 participants) testing safety and effectiveness. The combination may cause more side effects and may not improve outcomes over olaparib alone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
61 people
The number who actually took part.
- Started
-
Dec 2019
- Expected to finish
-
Feb 2027
An estimate. End dates often move.
- Lead sponsor
-
A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Female participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients must have platinum-sensitive, recurrent high-grade serous or high-grade endometrioid (grade 3) ovarian, primary peritoneal, or fallopian tube cancer. Patients with other histologies are also eligible, provided that the patient has a known deleterious germline or somatic BRCA1 or BRCA2 mutation identified through testing at a clinical laboratory. Submission of BRCA testing results (germline and/or somatic) is required for all patients. * Platinum-sensitive disease defined as no clinical or radiographic evidence of disease recurrence for \> 6 months (or 182 days) after last receipt of platinum-based therapy. The date should be calculated from the last administered dose of platinum therapy. * Patients must have had response (complete or partial) to their prior line of platinum therapy and cannot have had progression through prior platinum-based therapy. * Patients must have RECIST 1.1 measurable disease. Patients with biochemical recurrence based on CA125 levels alone are not eligible. * Prior therapy: * Prior chemotherapy must have included a first-line platinum-based regimen with or without consolidation chemotherapy. * Prior bevacizumab therapy as a component of frontline or recurrent treatment is permitted. * Patients may have received an unlimited number of platinum-based therapies in the recurrent setting. * Patients may have received up to one non-platinum-based line of therapy in the recurrent setting. Prior hormonal therapy will not be counted as this non-platinum-based line. * Prior treatment with a PARP inhibitor: * Patients may not have had a prior PARP inhibitor in the recurrent setting. * Prior use of a PARP inhibitor in the upfront maintenance setting is allowed for women with a confirmed BRCA1 or BRCA2 germline or somatic mutation. * Women who received a PARP inhibitor for maintenance therapy in the frontline setting must have received at least one other chemotherapy regimen for recurrence prior to enrolling on this trial. * Patients who demonstrated disease progression while on a PARP inhibitor are excluded. * Prior hormonal-based therapy for ovarian, primary peritoneal, or fallopian tube cancer is acceptable. * Age \>= 18. * Body weight \> 30 kg. * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 * Absolute neutrophil count (ANC) \>= 1,500/mcl (within 14 days prior to enrollment) * Platelets \>= 100,000/mcl (within 14 days prior to enrollment) * Hemoglobin \>= 10 g/dL (within 14 days prior to enrollment) * Note: blood transfusions are not permitted within 28 days prior to enrollment * Creatinine =\< 1.5 x institutional/laboratory upper limit of normal (ULN) (within 14 days prior to enrollment) * Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) (within 14 days prior to enrollment) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3 times institutional ULN (within 14 days prior to enrollment) * Adequately controlled thyroid function, with no symptoms of thyroid dysfunction and thyroid stimulating hormone (TSH) within normal limits. Thyroid replacement therapy is permitted to achieve a TSH within normal limits. * Patients must be able to swallow and retain oral medications and not have gastrointestinal illnesses that would preclude absorption of olaparib as judged by the treating physician. * Evidence of post-menopausal status or negative urinary or serum pregnancy test for pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply: * Women \< 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy). * Women \>= 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \> 1 year ago, had chemotherapy-induced menopause with last menses \> 1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy). * Administration of study drugs (olaparib, tremelimumab) may have an adverse effect on pregnancy and poses a risk to the human fetus, including embryo-lethality. Women of childbearing potential (WOCBP) must agree to use two (2) highly effective forms of contraception from up to 14 days prior to enrollment (for oral contraceptives), during treatment, and for 6 months after the last dose of study medication. * Life expectancy \>= 12 weeks. * Patients with brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression. Imaging studies must have been completed no later than 14 days prior to enrollment. In addition, patients must have been successfully weaned off steroid support. Patients should not have received steroids for the treatment of brain metastases within 14 days prior to enrollment. * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial * The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information. Exclusion Criteria: * Active infection requiring antibiotic therapy (except for uncomplicated urinary tract infections), including tuberculosis. * Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; and cirrhosis. For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. * Hormonal therapy directed at treatment for the cancer must be discontinued at least 28 days prior to enrollment. Hormone replacement therapy for symptom management is permitted. * Any other therapy directed at treating the cancer including chemotherapy, biologic/targeted agents, and immunologic agents, unless discontinued at least 28 days prior to enrollment. * Any radiation therapy unless discontinued at least 28 days prior to enrollment. * Major surgical procedure within 28 days prior to enrollment. * Current or prior use of immunosuppressive medication within 14 days before enrollment. The following are exceptions to this criterion: * Intranasal, inhaled, topical steroids, or local steroid injections (i.e. intra-articular injection) * Systemic corticosteroids at physiologic doses not to exceed 10mg/day of prednisone or its equivalent * Steroids as premedication for hypersensitivity reactions (i.e. computed tomography \[CT\] scan contrast allergy premedication). * Patients with active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, 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. * Patients with autoimmune disease (e.g., psoriasis, extensive atopic dermatitis, severe asthma, inflammatory bowel disease \[IBD\], multiple sclerosis \[M.S.\], uveitis, vasculitis) requiring concurrent use of any systemic immunosuppressants or steroids are excluded from the study. Patients with vitiligo, mild, intermittent asthma requiring only occasional beta-agonist inhaler use, or mild localized eczema are eligible. * Any patient with an allogeneic (allo)-transplant of any kind is excluded, including xenograft heart valve. * Chronic use of immune-suppressive drugs (i.e. systemic corticosteroids) for the management of cancer or non-cancer related illnesses (i.e. chronic obstructive pulmonary disease \[COPD\]). * Note: ongoing steroid use for the management of brain metastases is not permitted. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to olaparib or tremelimumab. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirements, substantially increase risk of incurring adverse events (AEs) or compromise the ability of the patient to give written informed consent. * Subjects must not have evidence of bowel obstruction on imaging or symptoms consistent with a bowel obstruction. Additional workup to rule this out is not required. * Known potent CYP3A4 inhibitors or inducers must be discontinued prior to starting treatment. * Symptoms associated with toxicities (\> Common Terminology Criteria for Adverse Event \[CTCAE version (v) 5.\] grade 2) caused by prior cancer therapy, excluding alopecia, vitiligo, and the laboratory values defined in the inclusion criteria. * Patients with grade \>= 2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Chair. * Patients who are receiving any other investigational agent. * Resting electrocardiogram (ECG) with corrected QT interval (QTc) \> 470 msec on two or more time points within a 24-hour period, or a family history of long QT syndrome. If an initial ECG is within normal limits, a repeat ECG is not required. * Patients who have previously received anti-CTLA-4 antibody therapy. * Blood transfusions are not permitted within 28 days prior to study enrollment. * Patients must not have signs or symptoms suggestive of myelodysplastic syndrome or acute myeloid leukemia. * Pregnant or lactating patients * Receipt of live attenuated vaccines within 30 days of enrollment. Note: patients, if enrolled, should not receive live vaccines while receiving study treatment and up to 30 days after the last treatment dose. Inactivated vaccines are permitted.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Fallopian tube endometrioid tumor are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Augusta University Medical Center
Augusta, Georgia, 30912, United States
-
Case Western Reserve University
Cleveland, Ohio, 44106, United States
-
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
-
Hartford Hospital
Hartford, Connecticut, 06102, United States
-
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
-
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
-
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
-
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
-
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
-
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045, United States
-
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio, 44122, United States
-
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
-
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
-
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
-
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106, United States
-
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
-
University of Virginia Cancer Center
Charlottesville, Virginia, 22908, United States
-
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298, United States
-
Washington University School of Medicine
St Louis, Missouri, 63110, United States
-
Women and Infants Hospital
Providence, Rhode Island, 02905, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a simple rinse reveal ovarian Cancer's earliest signs?
- Targeted pill aims to halt recurrent ovarian and endometrial cancers
- New drug combo aims to shrink Hard-to-Treat pancreatic and ovarian tumors
- New hope for Platinum-Resistant ovarian cancer: ONC201 and paclitaxel combo trial launches
- New targeted therapy shows promise for Tough-to-Treat ovarian cancer
- Engineered immune cells target Hard-to-Treat ovarian cancer