OVARIAN CANCER CLINICAL TRIALS
This list is a quick reference guide to several Phase 3 clinical trials that are currently recruiting in the United States. For assistance with searching for clinical trials, please contact our Helpline at info@bayareacancer.org or (650) 326-6686.
Terms Explained
Antibody-drug conjugate (ADC): an antibody is a protein that recognises a specific target. By attaching anti-cancer drugs, they can be delivered more directly to cancer cells, minimizing harm to healthy cells.
FRα: folate receptor alpha. It brings folate (vitamin B9) into cells. Healthy cells have small amounts of it; certain cancers have a lot. This makes it a good target for delivering chemotherapy selectively to cancer cells using ADCs..
PARP: poly ADP-ribose polymerase. These are enzymes that help cells to repair. Blocking it means cancer cells remain damaged and therefore die.
TROP2: trophoblast cell-surface antigen 2. Certain ovarian cancers have high quantities of this protein, making it a good target for delivering chemotherapy selectively to cancer cells using ADCs.
WEE1 kinase: a protein that helps regulate cell division. When blocked, cells divide in a damaged state, which leads to death of cancer cells.
Trial Name
Trial Type
What is being tested?
Why is this trial significant?
Who might qualify
Who is likely to be excluded?
New Drug
Two antibody-drug conjugates that target FRα (a key receptor in cancer cell growth) are being compared (the newer AZD5335 versus mirvetuximab soravtansine).
The trial is testing a new generation of this type of drug, and whether its use could be expanded to more people – those with lower expression of FRα.
- High grade serous ovarian, fallopian tube, or peritoneal cancer
- Platinum-resistant
- 1-3 prior lines of systemic treatment
- Endometrioid, clear cell, mucinous, or sarcomatous tumor histology; mixed tumors
- Refractory to platinum chemotherapy
- History of certain eye conditions, lung disease or bowel obstruction
New Drug
Azenosertib (ZN-c3), an oral inhibitor of WEE1 kinase) versus investigator’s choice of chemotherapy.
It investigates a targeted approach to a different part of the cancer cell growth pathway. WEE1 kinase allows damaged cancer cells to repair, and this blocks that process.
- High grade serous ovarian, fallopian tube, or peritoneal cancer
- Platinum-resistant
- Positive for Cyclin E1 Protein expression
- Prior therapy with azenosertib or any other WEE1 inhibitor, ATR inhibitor, CHK1/2 inhibitor, or PKMYT1 inhibitor
- Refractory to platinum chemotherapy
New Drug
INCB123667, an oral CDK2 inhibitor, versus investigator’s choice of chemotherapy.
Combined with the above trials, this further expands discovery of a targeted approach in platinum-resistant ovarian cancer. This focuses on another part of the cell growth pathway, CDK2.
- High grade serous ovarian, fallopian tube, or peritoneal cancer
- Platinum-resistant
- Positive for Cyclin E1 Protein expression
- Endometrioid, clear cell, mucinous, or sarcomatous tumor histology; mixed tumors
- Refractory to platinum chemotherapy
- History of significant cardiovascular or bowel disease
New Drug
Olvimulogene nanivacirepvec, a cancer vaccine, followed by platinum-doublet chemotherapy and bevacizumab – versus investigator’s-choice of chemotherapy with bevacizumab
This tests the idea that the vaccine treatment can re-sensitive the cancer cells to platinum.
- High grade serous, endometroid or clear cell ovarian, fallopian tube, or peritoneal cancer
- 3+ prior lines of systemic treatment
- Platinum-resistant or refractory
- Significant bowel disease or bleeding
- Unable to have an intraperitoneal catheter
- Prior virus-based cancer treatment
New Drug
This is a two part trial: sofetabart mipitecan versus chemotherapy or mirvetuximab soravtansine in platinum-resistant ovarian cancer; and sofetabart mipitecan plus bevacizumab versus platinum-based chemotherapy plus bevacizumab in platinum-sensitive ovarian cancer.
This also targets FRα and is a potential next generation drug of this category. It’s also looking at broader use – for both platinum-sensitive and platinum-resistant cancer types.
- High grade serous or endometroid ovarian, fallopian tube, or peritoneal cancer
- Radiographic progression on most recent systemic treatment
- Prior treatment with an antibody-drug conjugate using a topoisomerase
New Approach
Trastuzumab deruxtecan (an antibody-drug conjugate that targets HER2) + bevacizumab versus bevacizumab alone, as first-line maintenance treatment.
Trastuzumab has already been very effective in breast cancer. This investigates whether it plays a role in ovarian cancers expressing the same HER2 proteins.
- Newly diagnosed advanced (stage III–IV) ovarian, primary peritoneal, or fallopian tube cancer
- Tumor expresses HER2
- Received up to 6 cycles of standard of care bevacizumab in combination with platinum- based chemotherapy
- Eligible for PARP inhibitor
- Prior maintenance therapy
- History of bleeding disorder or certain lung diseases
New Drug
Sacituzumab tirumotecan (an antibody-drug conjugate that targets TROP2) with or without bevacizumab, versus existing standard best practice, for recurrent ovarian cancer.
This targets a different growth signal (TROP2) compared to many other ovarian cancer treatments, an opportunity for improving treatment of recurrent ovarian cancer.
- Locally advanced or metastatic epithelial ovarian, primary peritoneal, or fallopian tube cancer
- Already received platinum and carboplatin treatment
- First-line maintenance
- Received more than two prior types of treatment
- Inflammatory bowel disease, certain lung diseases or eye conditions
New Approach
Sacituzumab tirumotecan (an antibody-drug conjugate that targets TROP2) with or without bevacizumab, versus existing standard best practice, for first-line maintenance treatment.
Combined with the TroFuse-022 trial, this trial explores the role of drugs targeting a particular growth signal pathway, for different phases of ovarian cancer treatment.
- Stage III-IV ovarian, primary peritoneal, or fallopian tube cancer
- Completed platinum therapy
- Homologous recobination deficiency (HRD) positive, unknown or inconclusive
- Inflammatory bowel disease, certain lung diseases or eye conditions
New Approach
Avutometinib (a RAF/MEK “clamp”) + defactinib (a FAK inhibitor) versus investigator’s choice of chemo or hormone therapy.
RAF, MEK and FAK are all parts of cancer growth pathways. Targeting multiple at once is an attempt to reduce how cancer cells evade treatment. Low grade serous cancer is more chemotherapy-resistant so this trial explores a new approach in an area of need.
- Low-grade serous ovarian, fallopian or peritoneal cancer
- Documented KRAS status
- Progression or recurrence after ≥1 previous systemic treatment
- Prior treatment with FAK inhibitor
- Recent symptomatic bowel obstruction
- Significant eye, heart, or severe lung disease
New Approach
This explores the possible benefits of delivering heated chemotherapy plus a PARP inhibitor into the abdomen at the time of surgery.
- High grade serous or endometroid ovarian, fallopian or peritoneal cancer
- Stage III-IV
- Planned platinum-based neoadjuvant (before surgery) chemotherapy
- Cancer is deficient in DNA repair
- Not eligible for interval cytoreductive surgery
- Received neoadjuvant treatment other than platinum chemotherapy or bevacizumab
- Uncontrolled existing medical conditions