Colorectal NeoplasmsPhase 1/2NCT02484404
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
A Phase 1/2 study testing Olaparib, Cediranib and Durvalumab in people with Colorectal Neoplasms and Breast Neoplasms, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Durvalumab is a drug that may help people s immune systems respond to and kill cancer cells. Olaparib is a drug that may inhibit repairing DNA damage of cancer cells. Cediranib is a drug that may stop the blood vessel growth of cancer cells. This study has two components. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Colorectal Neoplasms, Breast Neoplasms
- What is being tested?
- Olaparib, Cediranib and Durvalumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2015to 30 Oct 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 51Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Phase I/II Study of the Anti-Programmed Death Ligand-1 Antibody Durvalumab (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Cancers
Background:
- Durvalumab is a drug that may help people s immune systems respond to and kill cancer cells. Olaparib is a drug that may inhibit repairing DNA damage of cancer cells. Cediranib is a drug that may stop the blood vessel growth of cancer cells. This study has two components. In the phase 1 component of the study, researchers want to investigate how well participants tolerate the combination of these drugs in treating advanced solid tumors, and in the phase 2 part of this study, researchers want to study if the combination treatments are effective in ovarian cancer.
Read more
Objectives:
- Phase 2 part of the study: To determine how effective this combination is in treating ovarian cancer.
Eligibility:
- Phase 2 part of the study: Adults age 18 or older with advanced or recurrent ovarian cancer that has no standard treatment.
Design:
- Participants will be screened with medical history, physical exam, and blood and urine tests. They will have CT or MRI scans. For these, they will lie in a machine that takes pictures of their bodies.
- Phase 2 part of the study requests the participants to have tumor samples removed.
- Participants will get Durvalumab through an IV. A small plastic tube will be inserted into a vein. The drug will be given every 4 weeks until disease progression.
- Participants will take olaparib or cediranib by mouth every day.
- Every 28 days will be 1 cycle. For cycle 1, participants will have 2 study visits. All other cycles, they will have 1 visit. At these visits, they will repeat the screening procedures.
- Patients will keep a drug and diarrhea diary.
- Patients on cediranib will monitor their blood pressure and keep a blood pressure diary.
- Participants who can become pregnant, or have a partner who can become pregnant, must practice an effective form of birth control.
- After 12 cycles, participants will have 1-3 months of follow-up.
Read the detailed description
Background:
Disruption of the immune checkpoint PD-1/PD-L1 pathway yielded clinical activity in subsets of advanced solid tumors, such as melanoma and lung cancer.
Olaparib (O), a PARP inhibitor (PARPi), has demonstrated single agent activity in recurrent ovarian cancer (OvCa), and subsets of prostate, triple negative breast or lung cancers.
Our recent randomized phase 2 study showed that O and cediranib (C), a VEGFR1-3 inhibitor was clinically superior to O alone in platinum-sensitive recurrent OvCa.
We hypothesize that increased DNA damage by PARP inhibition and/or reduced angiogenesis by VEGFR inhibition will complement the anti-tumor activity of an immune checkpoint inhibitor, Durvalumab, in recurrent OvCa and other solid tumors.
Objectives:
Phase I: To determine the recommended phase II dose (RP2D) and the safety of doublet therapies (Durvalumab/olaparib [Durvalumab+O] and Durvalumab/cediranib [Durvalumab+C]) and triplet therapy (Durvalumab+O+C) in patients with advanced solid tumors.
Phase II Cohort 2 non-small cell lung cancer (NSCLC); Durvalumab+O and Durvalumab+C arms: To determine clinical efficacy as measured by progression-free survival (PFS)
Phase II Cohort 3 small cell lung cancer (SCLC); Durvalumab+O arm: To determine clinical efficacy as measured by ORR
Phase II Cohort 4 metasttaic castrate-resistant prostate cancer (mCRPC); Durvalumab+O arm: To determine clinical efficacy as measured by PFS
Phase II Cohort 5 triple negative breast cancer (TNBC); Durvalumab+O arm: To determine clinical efficacy as measured by ORR
Phase II Cohort 1 OvCa; Durvalumab+O, Durvalumab+C and Durvalumab+O+C arms: To determine clinical efficacy as measured by overall response rate (ORR)
Phase II Cohort 6 colorectal cancer (CRC): C+Durvalumab arm: To determine clinical efficacy as measured by PFS
Eligibility:
Phase I: Advanced or recurrent solid tumors with evaluable disease.
Phase II Cohort 1 Durvalumab+O, Durvalumab+C and Durvalumab+O+C arms: Advanced or recurrent OvCa
Phase II Cohort 2 Durvalumab+O and Durvalumab+C arms: Advanced or recurrent NSCLC
Phase II Cohort 3 Durvalumab+O arm: Advanced or recurrent SCLC
Phase II Cohort 4 Durvalumab+O arm: mCRPC
Phase II Cohort 5 Durvalumab+O arm: Advanced or recurrent TNBC
Phase II Cohort 6 C+Durvalumab arm: Advanced or recurrent CRC
Patients must be off prior chemotherapy, radiation therapy or biologic therapy for at least 3 weeks. mCPRC patients (Cohort 4) may be on hormonal therapy with GnRH agonists/antagonists.
Adults with ECOG performance status 0-2, and adequate organ and marrow function.
Design:
Phase I: Durvalumab+O, Durvalumab+C and Durvalumab+O+C will dose escalate simultaneously. Durvalumab will be administered once every 2 weeks or once every 4 weeks until disease progression. O tablets and C will be given orally on a continuous or intermittent dosing schedule. The DLT period will be one cycle, 28 days. Patients on the 2-week schedule greater than one year will be changed to the 4-week schedule until progression.
Durvalumab+O: Durvalumab (3 mg/kg or 10 mg/kg IV every 2 weeks, or a fixed dose of 1500 mg every 4 weeks) and O tablets (150 mg or 200 mg or 300 mg BID)
Durvalumab+C: Durvalumab (3 mg/kg or 10 mg/kg IV every 2 weeks, or a fixed dose of 1500 mg every 4 weeks) and C (15 mg or 20 mg or 30 mg daily or 5 days/week)
Durvalumab+O+C: Durvalumab (a fixed dose of 1500mg every 4 weeks) with O tablets (200 mg or 300 mg BID) and C (15 mg or 20 mg 5 days/week)
Phase II Cohort 1 OvCa Durvalumab+O arm: Patients will be treated with Durvalumab+O at RP2D (O 300mg tablets bid daily and Durvalumab at 1500 mg IV every 4 weeks).
Phase II Cohort 1 OvCa Durvalumab+C arm: Patients will be treated with Durvalumab+C at RP2D (C 20mg once a day [5 days on/2 days off] and Durvalumab at 1500 mg every 4 weeks).
Phase II Cohort 1 OvCa Durvalumab+O+C arm: Patients with OvCa (Cohort 1) will be treated with RP2D (O tablets 300mg BID, C 20mg once a day [5 days on/2 days off] and Durvalumab at 1500 mg every 4 weeks).
Phase II Cohort 2 NSCLC; Durvalumab+O arm: Patients will be treated with Durvalumab+O at RP2D (O 300mg tablets bid daily and Durvalumab at 1500 mg IV every 4 weeks).
Phase II Cohort 2 NSCLC; Durvalumab+C arm: Patients will be treated with Durvalumab+C at RP2D (C 20mg once a day [5 days on/2 days off] and Durvalumab at 1500 mg every 4 weeks).
Phase II Cohort 3 SCLC; Durvalumab+O arm: Patients will be treated with Durvalumab+O at RP2D (O 300mg tablets bid daily and Durvalumab at 1500 mg IV every 4 weeks).
Phase II Cohort 4 mCRPC; Durvalumab+O arm: Patients will be treated with Durvalumab+O at RP2D (O 300mg tablets bid daily and Durvalumab at 1500 mg IV every 4 weeks).
Phase II Cohort 5 TNBC; Durvalumab+O arm: Patients will be treated with Durvalumab+O at RP2D (O 300mg tablets bid daily and Durvalumab at 1500 mg IV every 4 weeks).
Phase II Cohort 6 CRC; C+Durvalumab arm: Patients in the Cohort 6 will be treated with C 20mg daily alone for 14 days followed by the combination at RP2D (C 20mg once a day [5 days on/2 days off] and Durvalumab at 1500 mg every 4 weeks).
Phase II Correlative studies: Research samples including whole blood, CTCs, cell free DNA and plasma will be obtained at pretreatment, prior to cycle 1 day 15, prior to cycle 3 day 1 and at progression. Mandatory baseline core biopsy and two optional biopsies will be obtained.
Patients will be evaluated for toxicity every 4 weeks by CTCAEv4.0, and for response every two cycles (8 weeks) by RECIST 1.1. Patients with mCRPC (Durvalumab+O Cohort 4) will be evaluated for response initially at 8 weeks then every 12 weeks using RECIST v1.1 criteria as per the Prostate Cancer Clinical Trials Working Group 2 (PCWG2).
- Conditions
- Colorectal Neoplasms, Breast Neoplasms
- Being tested
- Olaparib, Cediranib, Durvalumab
- Keywords
- Immune Checkpoint Inhibitor, PARP Inhibitor, VEGFR Inhibitor
- Medical subject headings
- Colorectal Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlaparibDrug
Olaparib tablets will be given orally on a continuous dosing schedule. The DLT period will be one cycle, 28 days. MEDI4736 (3mg/kg or 10mg/kg IV) and Olaparib tablets (200 mg or 300 mg BID) Ph II - MEDI4736 + Olaparib at RP2D
CediranibDrug
Cediranib will be given orally on a continuous dosing schedule. The DLT period will be one cycle, 28 days. MEDI4736 (10mg/kg IV) and Cediranib (15 mg or 20 mg or 30 mg daily) Ph II - MEDI4736 + Cediranib at RP2D
DurvalumabDrug
Ph I - Durvalumab will be administered once every 2 weeks for 12 months.
| Study group | Role | What they receive |
|---|---|---|
| P1 Durvalumab+C | Experimental | Ph I Durvalumab + cediranib dose escalation Receives: Drug: Cediranib; Drug: Durvalumab |
| P1 Durvalumab+O | Experimental | Ph I Durvalumab + olaparib dose escalation Receives: Drug: Olaparib; Drug: Durvalumab |
| P1 Durvalumab+O+C | Experimental | Ph I Durvalumab + olaparib + cediranib dose escalation Receives: Drug: Olaparib; Drug: Cediranib; Drug: Durvalumab |
| P2 Durvalumab+C | Experimental | Ph II Durvalumab + cediranib at RP2D Receives: Drug: Cediranib; Drug: Durvalumab |
| P2 Durvalumab+O | Experimental | Ph II Durvalumab + olaparib at RP2D Receives: Drug: Olaparib; Drug: Durvalumab |
| P2 Durvalumab+O+C | Experimental | Ph II Durvalumab + olaparib + cediranib at RP2D Receives: Drug: Olaparib; Drug: Cediranib; Drug: Durvalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ph II Determine overall response rate of Durvalumab-O and Durvalumab-C in patients with recurrent ovarian cancer
Overall response rate
Measured: every 4 wks for toxicity and every 8 wks for response
Ph I Determine the recommended phase II dose (RP2D) and the safety of doublet therapies of Durvalumab/olaparib (Durvalumab-O) and Durvalumab/cediranib (Durvalumab-C) in patients with advanced solid tumors
Determination of the recommended phase II dose (RP2D) Safety: number of Adverse events
Measured: 28 days
Secondary outcomes (15)
Ph II Cohort 5 TNBC; Durvalumab+O arm: To determine PFS, safety by CTCAE v4.0, and potential relationship between pretreatment tumor PD-L1 expression obtained from biopsies and clinical response
ORR + safety (adverse events)
Measured: every 28 days, every 8 weeks
Ph II Cohort 4 mCRPC; Durvalumab+O arm: To determine ORR, safety by CTCAE v4.0, duration of response and PSA responses.
ORR + safety (adverse events), duration of response and PSA responses.
Measured: every 28 days, every 8 weeks
Ph II Cohort 3 SCLC; Durvalumab+O arm: To determine PFS and safety by CTCAE v4.0
PFS + Safety(adverse events)
Measured: every 28 days, every 8 weeks
Ph II Cohort 2 NSCLC; Durvalumab+O and Durvalumab+C arms: To determine ORR, and safety by CTCAE v4.0
ORR + Safety (adverse events)
Measured: every 28 days, every 8 weeks
Ph II Cohort 1 OvCa; Durvalumab+O, Durvalumab+C and Durvalumab+O+C arms: To evaluate PFS, safety by CTCAE v4.0, and potential relationship between pretreatment tumor PD-L1 expression obtained from biopsies and clinical response
Progression-Free Survival (PFS) + Safety (adverse events) + PD-L1 expression obtained from biopsies and clinical response
Measured: every 28 days, every 8 weeks
Ph I of triplet tx:explore changes in peripheral immune subsets, plasma cytokines and circulating endothelial cells with safety and/or clinical outcome of Durvalumab+O+C
Correlative laboratory research results + safety (adverse events) and/or clinical outcome
Measured: every 28 days
Ph I of triplet tx:determine the safety of Durvalumab+O+C
Safety (adverse events)
Measured: every 28 days
Ph I of triplet tx:determine the potential relationship between PD-L1 expression obtained from archival tissue samples and clinical response
PD-L1 expression obtained from archival tissue samples and clinical response
Measured: every 28 days
Ph I of triplet tx:determine the pharmacokinetics of the triplet and correlate with safety.
Pharmacokinetics + Safety: adverse events
Measured: Cycle 1 Days 1 and 15; Cycles 2 and beyond Day 1
Ph I of triplet tx::determine preliminary response rates of Durvalumab+O+C using RECIST v1.1
Response: Preliminary response rate
Measured: every 8 weeks
Ph I doublet:determine the potential relationship between PD-L1 expression obtained from archival tissue samples and clinical response
PD-L1 expression obtained from archival tissue samples and clinical response
Measured: every 28 days
Ph I doublet tx:determine preliminary response rates of the doublets using RECIST v1.1
Response: Preliminary response rate
Measured: every 8 wks
Ph I doublet tx: explore changes in peripheral immune subsets, plasma cytokines and circulating endothelial cells with safety and/or clinical outcome of Durvalumab+C
Correlative laboratory research results + safety (adverse events) and/or clinical outcome
Measured: every 28 days
Ph I doublet tx: determine the safety of the doublets, Durvalumab+O and Durvalumab+C
Safety: number of Adverse events
Measured: every 28 days
Ph I doublet tx: determine the pharmacokinetics of the doublets and correlate with safety.
Pharmacokinetics + Safety: adverse events
Measured: Cycle 1 Days 1 and 15; Cycles 2 and beyond Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study start29 Jun 2015
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Takeo Fujii, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02484404
- Sponsor's protocol ID
- 150145
- Other IDs
- 15-C-0145
- Status last verified
- 4 Nov 2026
- First submitted
- 25 Jun 2015
- Last updated
- 6 Nov 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@@@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.
Publications
Fialkoff G, Takahashi N, Sharkia I, Gutin J, Hermoni N, Nirula M, Kumar R, Pongor L, Nichols S, Sciuto L, Parmar K, Desai P, Suresh P, Abel M, El Meskini R, Maoz M, Rottenberg Y, Nevo S, Nechushtan H, Peretz T, Roame D, Hubert A, Cohen JE, Salah A, Temper M, Grinshpun A, Weaver-Ohler Z, Rajan A, Figg WD Sr, Zick A, Sadeh R, Friedman N, Thomas A. Plasma nucleosome profiling reports on tumor burden and molecular subtypes in small cell lung cancer. J Clin Invest. 2026 Oct 1;136(19):e202151. doi: 10.1172/JCI202151. eCollection 2026 Oct 1.
PubMed 42820295Santiago-Sanchez G, Rosato F, Fabian KP, Padget MR, Lee JM, Karzai F, Schlom J, Gulley JL, Hamilton DH, Lee JK, Pruitt MR, Bayliffe A, Su Z, Moisan J, Katragadda M, Hodge JW. PARP inhibition combined with a T-cell receptor beta chain-directed antibody fusion molecule drives polyclonal antitumor immunity and tumor regression. J Immunother Cancer. 2026 Jul 1;14(7):e014518. doi: 10.1136/jitc-2025-014518.
PubMed 42386344Li C, Madan RA, Lee MJ, Lee S, Sato N, Rastogi S, Shrestha R, Aragon-Ching JB, Goswami M, Donahue RN, Cordes LM, Baj A, Seo CCY, Terrigino NT, Bright JR, Hennigan ST, King IM, Trostel SY, Fenimore JM, Liu Y, Calzone KA, Schlom J, Gulley JL, Dahut WL, Figg WD, Sowalsky AG, Lee JM, Karzai F. Phase II study of olaparib and durvalumab in patients with metastatic castration-resistant prostate cancer. J Immunother Cancer. 2026 Mar 25;14(3):e014365. doi: 10.1136/jitc-2025-014365.
PubMed 41881502Fujii T, Cimino-Mathews A, Lipkowitz S, Lee MJ, Nair J, Solarz BB, Zimmer A, Redd B, Levy EB, Rastogi S, Sato N, McCoy A, Steinberg SM, Lee JM. A Phase II Pilot Study of Anti-PD-L1, Durvalumab, and a PARP Inhibitor, Olaparib in Patients With Metastatic Triple-Negative Breast Cancer With or Without Germline BRCA Mutation. Cancer Med. 2025 Dec;14(23):e71220. doi: 10.1002/cam4.71220.
PubMed 41360639Zimmer AS, Nichols E, Cimino-Mathews A, Peer C, Cao L, Lee MJ, Kohn EC, Annunziata CM, Lipkowitz S, Trepel JB, Sharma R, Mikkilineni L, Gatti-Mays M, Figg WD, Houston ND, Lee JM. A phase I study of the PD-L1 inhibitor, durvalumab, in combination with a PARP inhibitor, olaparib, and a VEGFR1-3 inhibitor, cediranib, in recurrent women's cancers with biomarker analyses. J Immunother Cancer. 2019 Jul 25;7(1):197. doi: 10.1186/s40425-019-0680-3.
PubMed 31345267Karzai F, VanderWeele D, Madan RA, Owens H, Cordes LM, Hankin A, Couvillon A, Nichols E, Bilusic M, Beshiri ML, Kelly K, Krishnasamy V, Lee S, Lee MJ, Yuno A, Trepel JB, Merino MJ, Dittamore R, Marte J, Donahue RN, Schlom J, Killian KJ, Meltzer PS, Steinberg SM, Gulley JL, Lee JM, Dahut WL. Activity of durvalumab plus olaparib in metastatic castration-resistant prostate cancer in men with and without DNA damage repair mutations. J Immunother Cancer. 2018 Dec 4;6(1):141. doi: 10.1186/s40425-018-0463-2.
PubMed 30514390
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of the Anti-Programmed Death Ligand-1 Antibody Durvalumab (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Cancers
- ClinicalTrials.gov ID
- NCT02484404
- Acronym / sponsor ID
- 150145
- Conditions
- Colorectal Neoplasms, Breast Neoplasms
- Keywords
- Immune Checkpoint Inhibitor, PARP Inhibitor, VEGFR Inhibitor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 268 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 29 Jun 2015 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 29 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.
Background:
- Durvalumab is a drug that may help people s immune systems respond to and kill cancer cells. Olaparib is a drug that may inhibit repairing DNA damage of cancer cells. Cediranib is a drug that may stop the blood vessel growth of cancer cells. This study has two components. In the phase 1 component of the study, researchers want to investigate how well participants tolerate the combination of these drugs in treating advanced solid tumors, and in the phase 2 part of this study, researchers want to study if the combination treatments are effective in ovarian cancer.
Objectives:
- Phase 2 part of the study: To determine how effective this combination is in treating ovarian cancer.
Eligibility:
- Phase 2 part of the study: Adults age 18 or older with advanced or recurrent ovarian cancer that has no standard treatment.
Design:
- Participants will be screened with medical history, physical exam, and blood and urine tests. They will have CT or MRI scans. For these, they will lie in a machine that takes pictures of their bodies.
- Phase 2 part of the study requests the participants to have tumor samples removed.
- Participants will get Durvalumab through an IV. A small plastic tube will be inserted into a vein. The drug will be given every 4 weeks until disease progression.
- Participants will take olaparib or cediranib by mouth every day.
- Every 28 days will be 1 cycle. For cycle 1, participants will have 2 study visits. All other cycles, they will have 1 visit. At these visits, they will repeat the screening procedures.
- Patients will keep a drug and diarrhea diary.
- Patients on cediranib will monitor their blood pressure and keep a blood pressure diary.
- Participants who can become pregnant, or have a partner who can become pregnant, must practice an effective form of birth control.
- After 12 cycles, participants will have 1-3 months of follow-up.
Detailed description
Background:
Disruption of the immune checkpoint PD-1/PD-L1 pathway yielded clinical activity in subsets of advanced solid tumors, such as melanoma and lung cancer.
Olaparib (O), a PARP inhibitor (PARPi), has demonstrated single agent activity in recurrent ovarian cancer (OvCa), and subsets of prostate, triple negative breast or lung cancers.
Our recent randomized phase 2 study showed that O and cediranib (C), a VEGFR1-3 inhibitor was clinically superior to O alone in platinum-sensitive recurrent OvCa.
We hypothesize that increased DNA damage by PARP inhibition and/or reduced angiogenesis by VEGFR inhibition will complement the anti-tumor activity of an immune checkpoint inhibitor, Durvalumab, in recurrent OvCa and other solid tumors.
Objectives:
Phase I: To determine the recommended phase II dose (RP2D) and the safety of doublet therapies (Durvalumab/olaparib [Durvalumab+O] and Durvalumab/cediranib [Durvalumab+C]) and triplet therapy (Durvalumab+O+C) in patients with advanced solid tumors.
Phase II Cohort 2 non-small cell lung cancer (NSCLC); Durvalumab+O and Durvalumab+C arms: To determine clinical efficacy as measured by progression-free survival (PFS)
Phase II Cohort 3 small cell lung cancer (SCLC); Durvalumab+O arm: To determine clinical efficacy as measured by ORR
Phase II Cohort 4 metasttaic castrate-resistant prostate cancer (mCRPC); Durvalumab+O arm: To determine clinical efficacy as measured by PFS
Phase II Cohort 5 triple negative breast cancer (TNBC); Durvalumab+O arm: To determine clinical efficacy as measured by ORR
Phase II Cohort 1 OvCa; Durvalumab+O, Durvalumab+C and Durvalumab+O+C arms: To determine clinical efficacy as measured by overall response rate (ORR)
Phase II Cohort 6 colorectal cancer (CRC): C+Durvalumab arm: To determine clinical efficacy as measured by PFS
Eligibility:
Phase I: Advanced or recurrent solid tumors with evaluable disease.
Phase II Cohort 1 Durvalumab+O, Durvalumab+C and Durvalumab+O+C arms: Advanced or recurrent OvCa
Phase II Cohort 2 Durvalumab+O and Durvalumab+C arms: Advanced or recurrent NSCLC
Phase II Cohort 3 Durvalumab+O arm: Advanced or recurrent SCLC
Phase II Cohort 4 Durvalumab+O arm: mCRPC
Phase II Cohort 5 Durvalumab+O arm: Advanced or recurrent TNBC
Phase II Cohort 6 C+Durvalumab arm: Advanced or recurrent CRC
Patients must be off prior chemotherapy, radiation therapy or biologic therapy for at least 3 weeks. mCPRC patients (Cohort 4) may be on hormonal therapy with GnRH agonists/antagonists.
Adults with ECOG performance status 0-2, and adequate organ and marrow function.
Design:
Phase I: Durvalumab+O, Durvalumab+C and Durvalumab+O+C will dose escalate simultaneously. Durvalumab will be administered once every 2 weeks or once every 4 weeks until disease progression. O tablets and C will be given orally on a continuous or intermittent dosing schedule. The DLT period will be one cycle, 28 days. Patients on the 2-week schedule greater than one year will be changed to the 4-week schedule until progression.
Durvalumab+O: Durvalumab (3 mg/kg or 10 mg/kg IV every 2 weeks, or a fixed dose of 1500 mg every 4 weeks) and O tablets (150 mg or 200 mg or 300 mg BID)
Durvalumab+C: Durvalumab (3 mg/kg or 10 mg/kg IV every 2 weeks, or a fixed dose of 1500 mg every 4 weeks) and C (15 mg or 20 mg or 30 mg daily or 5 days/week)
Durvalumab+O+C: Durvalumab (a fixed dose of 1500mg every 4 weeks) with O tablets (200 mg or 300 mg BID) and C (15 mg or 20 mg 5 days/week)
Phase II Cohort 1 OvCa Durvalumab+O arm: Patients will be treated with Durvalumab+O at RP2D (O 300mg tablets bid daily and Durvalumab at 1500 mg IV every 4 weeks).
Phase II Cohort 1 OvCa Durvalumab+C arm: Patients will be treated with Durvalumab+C at RP2D (C 20mg once a day [5 days on/2 days off] and Durvalumab at 1500 mg every 4 weeks).
Phase II Cohort 1 OvCa Durvalumab+O+C arm: Patients with OvCa (Cohort 1) will be treated with RP2D (O tablets 300mg BID, C 20mg once a day [5 days on/2 days off] and Durvalumab at 1500 mg every 4 weeks).
Phase II Cohort 2 NSCLC; Durvalumab+O arm: Patients will be treated with Durvalumab+O at RP2D (O 300mg tablets bid daily and Durvalumab at 1500 mg IV every 4 weeks).
Phase II Cohort 2 NSCLC; Durvalumab+C arm: Patients will be treated with Durvalumab+C at RP2D (C 20mg once a day [5 days on/2 days off] and Durvalumab at 1500 mg every 4 weeks).
Phase II Cohort 3 SCLC; Durvalumab+O arm: Patients will be treated with Durvalumab+O at RP2D (O 300mg tablets bid daily and Durvalumab at 1500 mg IV every 4 weeks).
Phase II Cohort 4 mCRPC; Durvalumab+O arm: Patients will be treated with Durvalumab+O at RP2D (O 300mg tablets bid daily and Durvalumab at 1500 mg IV every 4 weeks).
Phase II Cohort 5 TNBC; Durvalumab+O arm: Patients will be treated with Durvalumab+O at RP2D (O 300mg tablets bid daily and Durvalumab at 1500 mg IV every 4 weeks).
Phase II Cohort 6 CRC; C+Durvalumab arm: Patients in the Cohort 6 will be treated with C 20mg daily alone for 14 days followed by the combination at RP2D (C 20mg once a day [5 days on/2 days off] and Durvalumab at 1500 mg every 4 weeks).
Phase II Correlative studies: Research samples including whole blood, CTCs, cell free DNA and plasma will be obtained at pretreatment, prior to cycle 1 day 15, prior to cycle 3 day 1 and at progression. Mandatory baseline core biopsy and two optional biopsies will be obtained.
Patients will be evaluated for toxicity every 4 weeks by CTCAEv4.0, and for response every two cycles (8 weeks) by RECIST 1.1. Patients with mCRPC (Durvalumab+O Cohort 4) will be evaluated for response initially at 8 weeks then every 12 weeks using RECIST v1.1 criteria as per the Prostate Cancer Clinical Trials Working Group 2 (PCWG2).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| P1 Durvalumab+C | Experimental | Drug: Cediranib, Drug: DurvalumabPh I Durvalumab + cediranib dose escalation |
| P1 Durvalumab+O | Experimental | Drug: Olaparib, Drug: DurvalumabPh I Durvalumab + olaparib dose escalation |
| P1 Durvalumab+O+C | Experimental | Drug: Olaparib, Drug: Cediranib, Drug: DurvalumabPh I Durvalumab + olaparib + cediranib dose escalation |
| P2 Durvalumab+C | Experimental | Drug: Cediranib, Drug: DurvalumabPh II Durvalumab + cediranib at RP2D |
| P2 Durvalumab+O | Experimental | Drug: Olaparib, Drug: DurvalumabPh II Durvalumab + olaparib at RP2D |
| P2 Durvalumab+O+C | Experimental | Drug: Olaparib, Drug: Cediranib, Drug: DurvalumabPh II Durvalumab + olaparib + cediranib at RP2D |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (51 listed)
- 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.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| OlaparibOlaparib tablets will be given orally on a continuous dosing schedule. The DLT period will be one cycle, 28 days. MEDI4736 (3mg/kg or 10mg/kg IV) and Olaparib tablets (200 mg or 300 mg BID) Ph II - MEDI4736 + Olaparib at RP2D | Drug | P1 Durvalumab+O, P1 Durvalumab+O+C, P2 Durvalumab+O, P2 Durvalumab+O+C |
| CediranibCediranib will be given orally on a continuous dosing schedule. The DLT period will be one cycle, 28 days. MEDI4736 (10mg/kg IV) and Cediranib (15 mg or 20 mg or 30 mg daily) Ph II - MEDI4736 + Cediranib at RP2D | Drug | P1 Durvalumab+C, P1 Durvalumab+O+C, P2 Durvalumab+C, P2 Durvalumab+O+C |
| DurvalumabPh I - Durvalumab will be administered once every 2 weeks for 12 months. | Drug | P1 Durvalumab+C, P1 Durvalumab+O, P1 Durvalumab+O+C, P2 Durvalumab+C, P2 Durvalumab+O, P2 Durvalumab+O+C |
Primary outcome
Ph II Determine overall response rate of Durvalumab-O and Durvalumab-C in patients with recurrent ovarian cancer
Time frame: every 4 wks for toxicity and every 8 wks for response
Overall response rate
Ph I Determine the recommended phase II dose (RP2D) and the safety of doublet therapies of Durvalumab/olaparib (Durvalumab-O) and Durvalumab/cediranib (Durvalumab-C) in patients with advanced solid tumors
Time frame: 28 days
Determination of the recommended phase II dose (RP2D) Safety: number of Adverse events
15 secondary outcomes
Ph II Cohort 5 TNBC; Durvalumab+O arm: To determine PFS, safety by CTCAE v4.0, and potential relationship between pretreatment tumor PD-L1 expression obtained from biopsies and clinical response
Time frame: every 28 days, every 8 weeks
Ph II Cohort 4 mCRPC; Durvalumab+O arm: To determine ORR, safety by CTCAE v4.0, duration of response and PSA responses.
Time frame: every 28 days, every 8 weeks
Ph II Cohort 3 SCLC; Durvalumab+O arm: To determine PFS and safety by CTCAE v4.0
Time frame: every 28 days, every 8 weeks
Ph II Cohort 2 NSCLC; Durvalumab+O and Durvalumab+C arms: To determine ORR, and safety by CTCAE v4.0
Time frame: every 28 days, every 8 weeks
Ph II Cohort 1 OvCa; Durvalumab+O, Durvalumab+C and Durvalumab+O+C arms: To evaluate PFS, safety by CTCAE v4.0, and potential relationship between pretreatment tumor PD-L1 expression obtained from biopsies and clinical response
Time frame: every 28 days, every 8 weeks
Ph I of triplet tx:explore changes in peripheral immune subsets, plasma cytokines and circulating endothelial cells with safety and/or clinical outcome of Durvalumab+O+C
Time frame: every 28 days
Ph I of triplet tx:determine the safety of Durvalumab+O+C
Time frame: every 28 days
Ph I of triplet tx:determine the potential relationship between PD-L1 expression obtained from archival tissue samples and clinical response
Time frame: every 28 days
Ph I of triplet tx:determine the pharmacokinetics of the triplet and correlate with safety.
Time frame: Cycle 1 Days 1 and 15; Cycles 2 and beyond Day 1
Ph I of triplet tx::determine preliminary response rates of Durvalumab+O+C using RECIST v1.1
Time frame: every 8 weeks
Ph I doublet:determine the potential relationship between PD-L1 expression obtained from archival tissue samples and clinical response
Time frame: every 28 days
Ph I doublet tx:determine preliminary response rates of the doublets using RECIST v1.1
Time frame: every 8 wks
Ph I doublet tx: explore changes in peripheral immune subsets, plasma cytokines and circulating endothelial cells with safety and/or clinical outcome of Durvalumab+C
Time frame: every 28 days
Ph I doublet tx: determine the safety of the doublets, Durvalumab+O and Durvalumab+C
Time frame: every 28 days
Ph I doublet tx: determine the pharmacokinetics of the doublets and correlate with safety.
Time frame: Cycle 1 Days 1 and 15; Cycles 2 and beyond Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Derived from this study: PubMed 42820295Fialkoff G, Takahashi N, Sharkia I, Gutin J, Hermoni N, Nirula M, Kumar R, Pongor L, Nichols S, Sciuto L, Parmar K, Desai P, Suresh P, Abel M, El Meskini R, Maoz M, Rottenberg Y, Nevo S, Nechushtan H, Peretz T, Roame D, Hubert A, Cohen JE, Salah A, Temper M, Grinshpun A, Weaver-Ohler Z, Rajan A, Figg WD Sr, Zick A, Sadeh R, Friedman N, Thomas A. Plasma nucleosome profiling reports on tumor burden and molecular subtypes in small cell lung cancer. J Clin Invest. 2026 Oct 1;136(19):e202151. doi: 10.1172/JCI202151. eCollection 2026 Oct 1.
- Derived from this study: PubMed 42386344Santiago-Sanchez G, Rosato F, Fabian KP, Padget MR, Lee JM, Karzai F, Schlom J, Gulley JL, Hamilton DH, Lee JK, Pruitt MR, Bayliffe A, Su Z, Moisan J, Katragadda M, Hodge JW. PARP inhibition combined with a T-cell receptor beta chain-directed antibody fusion molecule drives polyclonal antitumor immunity and tumor regression. J Immunother Cancer. 2026 Jul 1;14(7):e014518. doi: 10.1136/jitc-2025-014518.
- Derived from this study: PubMed 41881502Li C, Madan RA, Lee MJ, Lee S, Sato N, Rastogi S, Shrestha R, Aragon-Ching JB, Goswami M, Donahue RN, Cordes LM, Baj A, Seo CCY, Terrigino NT, Bright JR, Hennigan ST, King IM, Trostel SY, Fenimore JM, Liu Y, Calzone KA, Schlom J, Gulley JL, Dahut WL, Figg WD, Sowalsky AG, Lee JM, Karzai F. Phase II study of olaparib and durvalumab in patients with metastatic castration-resistant prostate cancer. J Immunother Cancer. 2026 Mar 25;14(3):e014365. doi: 10.1136/jitc-2025-014365.
- Derived from this study: PubMed 41360639Fujii T, Cimino-Mathews A, Lipkowitz S, Lee MJ, Nair J, Solarz BB, Zimmer A, Redd B, Levy EB, Rastogi S, Sato N, McCoy A, Steinberg SM, Lee JM. A Phase II Pilot Study of Anti-PD-L1, Durvalumab, and a PARP Inhibitor, Olaparib in Patients With Metastatic Triple-Negative Breast Cancer With or Without Germline BRCA Mutation. Cancer Med. 2025 Dec;14(23):e71220. doi: 10.1002/cam4.71220.
- Derived from this study: PubMed 31345267Zimmer AS, Nichols E, Cimino-Mathews A, Peer C, Cao L, Lee MJ, Kohn EC, Annunziata CM, Lipkowitz S, Trepel JB, Sharma R, Mikkilineni L, Gatti-Mays M, Figg WD, Houston ND, Lee JM. A phase I study of the PD-L1 inhibitor, durvalumab, in combination with a PARP inhibitor, olaparib, and a VEGFR1-3 inhibitor, cediranib, in recurrent women's cancers with biomarker analyses. J Immunother Cancer. 2019 Jul 25;7(1):197. doi: 10.1186/s40425-019-0680-3.
- Derived from this study: PubMed 30514390Karzai F, VanderWeele D, Madan RA, Owens H, Cordes LM, Hankin A, Couvillon A, Nichols E, Bilusic M, Beshiri ML, Kelly K, Krishnasamy V, Lee S, Lee MJ, Yuno A, Trepel JB, Merino MJ, Dittamore R, Marte J, Donahue RN, Schlom J, Killian KJ, Meltzer PS, Steinberg SM, Gulley JL, Lee JM, Dahut WL. Activity of durvalumab plus olaparib in metastatic castration-resistant prostate cancer in men with and without DNA damage repair mutations. J Immunother Cancer. 2018 Dec 4;6(1):141. doi: 10.1186/s40425-018-0463-2.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@@@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.
Related trials for Colorectal Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
Takeo Fujii, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Olaparib, Cediranib and Durvalumab in people with Colorectal Neoplasms and Breast Neoplasms, run by National Cancer Institute (NCI) 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 51 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Ph II Determine overall response rate of Durvalumab-O and Durvalumab-C in patients with recurrent ovarian cancer (time frame: every 4 wks for toxicity and every 8 wks for response). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02484404, which also lists 6 linked publications.
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 6 Nov 2026.