Phase 3 Study of Nemvaleukin Alfa in Combination With Pembrolizumab in Patients With Platinum-Resistant Epithelial Ovarian Cancer (ARTISTRY-7)
L
Lisa Landrum, MD, PhD, MS
Primary Investigator
Enrolling By Invitation
18 years and older
Female
Phase
3
376 participants needed
3 Locations
Brief description of study
What is the purpose of this study?
This is a Phase 3, multicenter, open-label, randomized study of nemvaleukin in combination
with pembrolizumab versus protocol-specific Investigator's choice chemotherapy in patients
with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office
Email: iutrials@iu.edu
Phone: (317) 278-5632
Detailed description of study
What will happen during the study?
- Patients will be centrally allocated in a randomized fashion (3:1:1:3) to receive either:
- Arm 1: Nemvaleukin and pembrolizumab combination therapy Arm 2: Pembrolizumab monotherapy Arm 3: Nemvaleukin monotherapy Arm 4: Investigator's choice chemotherapy include one of thewing: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Platinum-resistant Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
-
Age: 18 Years
-
Gender: Female
Inclusion Criteria:
- Patient is female and ≥18 years of age.
- Patient has histologically confirmed diagnosis of EOC (ie, high-grade serous,dometrioid of any grade, clear cell), fallopian tube cancer, or primary peritoneal.
- Patient has platinum-resistant/refractory disease, defined as disease progressionwithin 180 days following the last administered dose of platinum therapy beyondg (resistant) or lack of response or disease progression whileving the most recent platinum-based therapy (refractory). Patient must havegressed radiographically on or after their most recent line of anticancer therapy.
- Patient must have received at least 1 prior line of systemic anticancer therapy in theum sensitive setting, and no more than 5 prior lines of systemic anticancerherapy in the platinum-resistant setting. Patient must have received at least 1 lineherapy containing bevacizumab.
- Patient has at least one measurable lesion that qualifies as a target lesion based onRECISTv1.1.
- Patient is willing to undergo a pre-treatment tumor biopsy or provide qualifyinghival tumor tissue.
Exclusion Criteria:
- Patient has primary platinum-refractory disease or primary platinum resistance,defined as disease progression during first-line platinum-based therapy (refractory)disease progression <3 months after completion of first-line platinum-based therapy(resistant).
- Patient has histologically confirmed diagnosis of EOC with mucinous or carcinosarcomaubtype.
- Patient has nonepithelial tumor (eg, germline or stromal cell tumor) or ovarian tumorwith low malignant potential (ie, borderline or low-grade serous tumor).
- Patient requires fluid drainage (eg, paracentesis, thoracentesis, pericardiocentesis)≥500 mL within 6 weeks of first dose of study drug.
- Patient has received prior IL-2-based or IL-15-based cytokine therapy; patient has hadure, including intralesional, to IL-12 or analogs thereof.
- Patient has prior exposure to any anti-PD1/PD-L1 therapy.
Updated on
01 Aug 2024.
Study ID: ALKS 4230-007, CTO-GOG-3063, 15811
Please visit our main page to search for other studies you may be interested in.
If you need help finding a study or have any questions, please contact us at inhealth@iu.edu
