New drug cocktail shows promise for Tough-to-Treat ovarian cancer
NCT ID NCT02484404
First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 7 times
Summary
This study tests three drugs—durvalumab (an immunotherapy), olaparib (a DNA repair blocker), and cediranib (a blood vessel growth blocker)—in different combinations for people with advanced solid tumors, especially ovarian cancer. The phase 1 part finds safe doses, and the phase 2 part checks if the combinations shrink tumors in recurrent ovarian cancer. About 268 adults with no standard treatment options are taking part.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- durvalumab (immunotherapy) combined with olaparib (PARP inhibitor) or cediranib (anti-angiogenic drug)
- What this could lead to
- If successful, this could provide a new treatment option for advanced or recurrent ovarian cancer that has stopped responding to standard therapies.
- What could go wrong
- This is an early-phase trial (phase 1/2) with a small number of participants, so results may not apply to all patients. The drug combinations can cause side effects like high blood pressure, fatigue, and immune-related reactions.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
268 people
The number who actually took part.
- Started
-
Jun 2015
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 99 years
- Sex
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Anyone
- Healthy volunteers
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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.
* ELIGIBILITY: INCLUSION CRITERIA GENERAL: * Patients must be at least 18 years of age. * Patients must have adequately controlled blood pressure on a maximum of three antihypertensive medications. * Patients who have the following clinical conditions are considered to be at increased risk for cardiac toxicities. Patients with any cardiac history of the following conditions within 1 year prior to study enrollment are excluded from the study: * Prior events including myocardial infarction, pericardial effusion, and myocarditis. * Prior cardiac arrhythmia including atrial fibrillation and atrial flutter, or requiring concurrent use of drugs or biologics with pro-arrhythmic potential. * NYHA Class II or greater heart failure. * If cardiac function assessment is clinically indicated or performed, an LVEF less than normal per institutional guidelines, or \<55%, if threshold for normal is not otherwise specified by institutional guidelines. * QTc prolongation \>470 msec or other significant ECG abnormality noted within 14 days of treatment. * Hypertensive crisis or hypertensive encephalopathy. * Clinically significant peripheral vascular disease or vascular disease, including rapidly growing aortic aneurysm or abdominal aortic aneurysm \>5 cm or aortic dissection. * Unstable angina. * Eligibility for patients with asymptomatic and a previous diagnosis of immune or inflammatory colitis, or patients with chronic diarrhea \> 1 month without immune or inflammatory colitis is a PI decision on an individual patient basis. * Patients with a history of cerebrovascular accident or transient ischemic attack within 1 year prior to study enrollment are not eligible. * Patients with a history of previous clinical diagnosis of tuberculosis are not eligible. * Patients with a history of auto-immune disease requiring steroid maintenance, or history of primary immunodeficiency are not eligible. * HIV-positive patients on antiretroviral therapy are ineligible because of potential pharmacokinetic interactions with study drugs, however, patients with long-standing (\>5 years) HIV on antiretroviral therapy \> 1 month (undetectable HIV viral load and CD4 count \> 150 cells/microL) may be eligible if the PI determines no anticipated clinically significant drug-drug interactions. * HBV-or HCV-positive patients are ineligible because of potential reactivation of hepatitis virus following steroids. * Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to MEDI4736, olaparib, cediranib, or to other humanized monoclonal antibodies, or a history of anaphylaxis, angioedema, laryngeal edema, serum sickness, or uncontrolled asthma, are not eligible. * Patients who have had prior immune checkpoint inhibitors, such as MEDI4736 or other PD1 or PD-L1 inhibitors or an anti-CTLA4 therapy are eligible. * Pregnant and breastfeeding women are excluded from this study. * Patients with any other concomitant or prior invasive malignancies are ineligible. PHASE II MEDI4736 PLUS OLAPARIB OR CEDIRANIB STUDY ELIGIBILITY CRITERIA - OVARIAN CANCER * Patients must have histologically or cytologically confirmed persistent or recurrent ovarian, fallopian tube, or primary peritoneal cancer and have received at least two prior regimens or who are platinum resistant or refractory during or after a first platinum containing regimen. * Patients must have at least one lesion deemed safe to biopsy and be willing to undergo a mandatory baseline biopsy. * Patients are allowed to have received prior PARPi, and/or anti-angiogenesis therapy including but not limited to thalidomide, bevacizumab, sunitinib, sorafenib, or other anti-angiogenics. However, patients who were treated with both olaparib and cediranib, either in combination or sequentially are not eligible. For this study, BSI-201 (iniparib) is not considered as PARPi. PHASE II STUDY MEDI4736 PLUS OLAPARIB ELIGIBILITY CRITERIA TRIPLE NEGATIVE BREAST CANCER * Patients must have histologically confirmed persistent or recurrent triple-negative breast cancer (TNBC) * ER/PR/HER2 status needs to be documented either by an outside source or at NCI. * Documentation of germline BRCA1 and BRCA2 mutation (gBRCAm) status will be required for eligibility. * Patients must have measurable disease as defined by RECIST v1.1. * Patients must have at least one lesion deemed safe to biopsy and be willing to undergo a mandatory baseline biopsy. * Patients who have received prior PARPi are ineligible. * Patients must not have evidence of CNS metastasis or leptomeningeal disease within one year prior to enrollment. PHASE II MEDI4736 PLUS OLAPARIB OR CEDIRANIB STUDY ELIGIBILITY CRITERIA - NON-SMALL CELL LUNG CANCER * Histologically or cytologically confirmed advanced NSCLC with at least one prior line of platinum-based chemotherapy (or treatment with EGFR, ALK, or BRAF-targeted tyrosine kinase inhibitors if tumors harbor an EGFR-sensitizing mutation, ALK translocation, or BRAF V600E mutation, respectively). * Patients must have measurable disease as defined by RECIST v1.1. * Patients must have at least one lesion deemed safe to biopsy and be willing to undergo a mandatory baseline biopsy. * Patients who have received anti-angiogenesis therapy are eligible, including but not limited to thalidomide, bevacizumab, sunitinib, sorafenib, or other anti-angiogenics. However, patients who were treated with cediranib, either in combination or monotherapy are not eligible. * Current or prior use of immunosuppressive medication within 28 days before the first dose of MEDI4736, with the exception of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone or an equivalent corticosteroid. * Patients who have had prior PARPi are not eligible. * Patients with prior history of pneumonitis and/or interstitial lung disease will be excluded. PHASE II MEDI4736 PLUS OLAPARIB STUDY ELIGIBILITY CRITERIA - METASTATIC CASTRATE-RESISTANT PROSTATE CANCER * Patients must have metastatic, progressive, castrate resistant prostate cancer (mCRPC). * All patients must have at least one lesion deemed safe to biopsy and be willing to undergo a mandatory baseline biopsy. * Patients must have received prior treatment with enzalutamide and/or abiraterone with the exception of patients who were treated with docetaxel and androgen deprivation therapy for metastatic castrate-sensitive prostate cancer and progressed on docetaxel treatment or who progress within one month of the last docetaxel dose. * Patients must have undergone bilateral surgical castration or must agree to continue on GnRH agonists/antagonists for the duration of the study. * Patients who have had progression of prostate cancer on prior docetaxel treatment for castrate sensitive disease are ineligible. * Patients who have had prior treatment with PARPi are not eligible. * Patients who have received radionuclide treatment within 6 weeks prior to the first dose of the study treatment are not eligible. * Patients with any other concomitant or prior invasive malignancies are ineligible.
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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
-
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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