RECURRENT ENDOMETRIAL CANCER TRIALS

Question 1

Study #: MANU

Uterine MANipUlation During Minimally Invasive Surgery for Early Stage Endometrial Cancer (MAN-U Trial)

Schema:

1:1

• Arm MAN UA (experimental arm): MIS surgery WITH uterine manipulator.
• Arm CONTROL (reference arm): MIS surgery WITHOUT uterine manipulator.

Prior Therapy:

N/A

Measurable Disease:

N/A

Answer 1

Inclusion:

•Patient must be ≥ 18 years old.

•Suspected clinically early stage endometrial cancer of any histology (endometrioid, mixed, serous, clear-cell, carcinosarcomas, mucinous).

•Pre-operative imaging not suggestive of extra-uterine disease, if obtained pre-operatively.

• CA 125 testing is optional, but if obtained, must be within lab normal values.

• ECOG performance status 0-2

Exclusion:

• Planned laparotomic hysterectomy

• On progesterone therapy to treat their endometrial cancer

• Any prior pelvic radiation

Question 2

Study #: NRGGY012

A Randomized Phase II Study Comparing Single-Agent Olaparib, Single Agent Cediranib, and the Combinations of Cediranib/Olaparib, Olaparib/Durvalumab (MEDI4736), Cediranib/Durvalumab (MEDI4736), Olaparib/AZD5363 (Capivasertib) in Women with Recurrent, Persistent or Metastatic Endometrial Cancer.: A Platform Trial for Women with Recurrent or Persistent Endometrial Cancer

Schema:

Randomized 1:1:1:1

Cediranib

Olaparib + Capivasertib

Olaparib + Durvalumab

Cediranib + Durvalumab

Prior Therapies:

• Must receive at least 1 prior line (chemotx, chemotx & radiotx, and/or mantenance tx)

• Immunotherapy and non cytotoxic therapies allowed

•Excluding: drugs on trial, lenvatinib & pembrolizumab for recurrent/persistent disease

• Immune checkpoint (excluding durvalumab) allowed

Answer 2

Measurable Disease:

No (must have detectable disease)

• Ascites and/or pleural effusion attributed to tumor.

• Solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST 1.1)

Inclusion:

• Patients must have recurrent or persistent endometrial carcinoma, which is refractory to curative therapy or established treatments.

• ECOG 0-2

• Adequate BP control

• Adequate Thyroid control

• Stable cardiac function

Exclusion:

• Clear cell and carcinosarcoma histology is excluded.

• Patients who require steriods for prior immune related colitis

• Prior enrollment into a clinical trial including cediranib or olaparib.

• Current signs/symptoms of bowel obstruction and/or signs/symptoms of bowel obstruction within the preceding 3 months

• History of gastrointestinal perforation.

• Uncontrolled intercurrent illness

• Prior history of stroke or transient ischemic attack within the last 6 months.

• Other malignancy within the last 5 years: exception- basal cell or squamour cell carcinoma of skin, curatively treated other solid tumors

• Patients with active autoimmune disease or history of autoimmune disease that might recur