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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT03026062

NCT03026062
Completed Phase 2

Who may be able to join

Who might be able to join this trial:

  • You are 18 years of age or older.
  • You are able to carry out normal daily activities, or have only minor limitations due to your illness (confirm with trial site).
  • Your blood counts and organ function (including blood cells, liver, and kidneys) are within acceptable levels based on recent lab tests.
  • You are either not able to become pregnant (for example, due to menopause, hysterectomy, or surgical sterilization), or you have a negative pregnancy test at the start of the study.
  • You are willing and able to attend all required visits, treatments, and procedures, including tissue biopsies, for the full duration of the study.
  • You have been diagnosed with recurrent high-grade ovarian, peritoneal, or fallopian tube cancer of a specific type called "clear cell," or a mixed type that includes a clear cell component — confirmed by review at MD Anderson Cancer Center.
  • You may also be eligible if you have recurrent uterine serous cancer with a specific gene change called a PPP2R1A mutation (or a related mutation approved by the study doctor), confirmed by approved genetic testing.
  • Your cancer has come back or continued to grow during or within 6 months of platinum-based chemotherapy (this does not apply to uterine serous cancer patients, but they must have received at least one prior platinum-based treatment).
  • You have at least one measurable tumor that can be clearly measured on a scan or imaging, and your most recent imaging was done within 4 weeks of starting treatment.
  • You have signed a written consent form agreeing to take part in the study.

Who may not be able to join:

  • You are involved in planning or running this study.
  • You have previously been enrolled in this same study.
  • You have taken part in another clinical trial using an experimental treatment within the past 28 days.
  • You have previously been treated with certain immunotherapy drugs, including PD-1 or PD-L1 inhibitors (such as Durvalumab), CTLA-4 inhibitors (such as Tremelimumab), or adoptive T cell therapy.
  • You have had another cancer in the past, unless it was treated successfully with no signs of return for at least 5 years, or it was a minor skin cancer or pre-cancerous condition that was fully treated.
  • You received cancer treatment (such as chemotherapy, immunotherapy, or targeted therapy) within the past 28 days (or longer for certain specific treatments — confirm with trial site).
  • You have a heart rhythm abnormality of a specific type detected on an ECG (electrocardiogram) test (confirm with trial site).
  • You have used medications that suppress your immune system within the past 28 days, except for low-dose steroids or inhaled/nasal steroid sprays.
  • You still have side effects from previous cancer treatment that have not fully resolved, except for hair loss.
  • You previously had a severe (grade 3 or higher) immune-related reaction from immunotherapy, or you still have unresolved immune-related side effects.
  • You have or have had an autoimmune disease (where the immune system attacks the body) in the past 2 years — though some conditions like vitiligo or mild psoriasis not needing treatment may be acceptable.
  • You have or have had inflammatory bowel disease, such as Crohn's disease or ulcerative colitis.
  • You have a history of a condition where your immune system does not work properly from birth (primary immunodeficiency).
  • You have received an organ transplant from another person.
  • You have had a known allergic reaction to Durvalumab, Tremelimumab, or any of their ingredients.
  • You have an uncontrolled ongoing illness, active infection, uncontrolled heart condition, uncontrolled high blood pressure, active hepatitis B, hepatitis C, HIV, or a mental health condition that would affect your ability to participate safely.
  • You have a known history of tuberculosis.
  • Your cancer has spread to the fluid around the brain or spinal cord, or to the brain itself.
  • You have a bowel blockage that has not been resolved.
  • You have received a live vaccine within 30 days before starting the study or within 30 days of receiving the study drugs.
  • You are pregnant, breastfeeding, or able to become pregnant and are not willing or able to use

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 2
Sponsor
M.D. Anderson Cancer Center
Registry
clinicaltrials_gov
Start date
18 May 2017
Est. completion
11 September 2025

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Immune-related progression-free survival (irPFS)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov