Health TrialsbyHealthPanel

A Study of Lorigerlimab in Participants With Advanced Solid Tumors

ConditionsPlatinum-resistant Ovarian CancerPlatinum-Resistant Fallopian Tube CarcinomaPlatinum-Resistant Primary Peritoneal CarcinomaClear Cell Adenocarcinoma of OvaryClear Cell Adenocarcinoma of VulvaClear Cell Adenocarcinoma of VaginaClear Cell Adenocarcinoma of CervixClear Cell Adenocarcinoma of UterusClear Cell Adenocarcinoma of Fallopian TubeClear Cell Adenocarcinoma of PeritoneumEndometrial Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMacroGenics

About this trial

Study CP-MGD019-03 is an open-label study of lorigerlimab in participants with platinum-resistant ovarian cancer (PROC) or clear cell gynecologic cancer (CCGC). Approximately 80 participants will be enrolled. The study will assess the efficacy and safety of lorigerlimab in participants with PROC or CCGC.

Participants will receive lorigerlimab by intravenous (IV) infusion on Day 1 of every 21-day treatment cycle. Treatment cycles will continue until progression of cancer, unacceptable side effects, withdrawal of consent by the participant, or the study ends.

Participants will be monitored closely for side effects by physical exam and routine laboratory tests every cycle. Tumor status will be checked approximately every 9 weeks for the first year, then every 12 weeks for the duration of treatment. Participants will have a safety followup performed within 30 days after treatment discontinuation. Participants who discontinue study treatment for reasons other than progression of cancer, will continue CA-125 and tumor assessments every 12 weeks. Participants who discontinue study treatment for progression of cancer will enter the 6-month survival follow up portion of the study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed high-grade serous epithelial ovarian cancer, including primary peritoneal, or fallopian tube cancer, resistant to platinum based chemotherapy. OR

Histologically confirmed clear cell carcinoma of the ovary (including primary peritoneal and fallopian tube), endometrium, vagina, vulva, or cervix.

Persistent or recurrent disease with documented disease progression.

Participants with PROC must have received at least 1 but not more than 3 prior lines of therapy for PROC.

Disqualifiers

Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures.

Primary platinum-refractory disease, defined as disease that did not respond to (CR or PR) or has progressed within 3 months of the last dose of first-line platinum- containing chemotherapy.

Prior treatment with a checkpoint inhibitor (e.g., anti-PD-1/PD-L1, anti-PD-L2, anti-CTLA-4). Prior use of immune checkpoint inhibitors (e.g., anti-PD-1, anti-PD-L1, anti-CTLA-4) is allowed for clear cell endometrial and clear cell cervical cancer.

Active brain metastases or leptomeningeal metastases.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lorigerlimab

    Biological/Vaccine

    Bispecific DART protein binding PD-1 and CTLA-4

Treatment groups

80 Participants
are divided into 4 treatment groups
Group A: Cohort A (PROC) high doseExperimental treatment 1 intervention
Group B: Cohort A (PROC) low doseExperimental treatment 1 intervention
Group C: Cohort B (CCGC)Experimental treatment 1 intervention
Group D: Cohort C (CCGC)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria as determined by the investigator

The ORR, is defined as the percentage of patients in the response evaluable population who achieve a best overall response of complete response (CR) or partial response (PR), per RECIST, version 1.1 criteria. CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease from baseline in the sum of diameters of target lesions.

Time frame
Throughout the study up to approximately 2 years

Secondary outcomes

1

Frequency and severity of adverse events (AEs), serious AEs (SAEs), immune-related AEs (irAEs), and AEs leading to dose modifications or treatment discontinuation.

Time frame
Throughout the study, up to approximately 2 years
2

Median duration of response (DoR) per RECIST 1.1 criteria

The DoR will be calculated per RECIST v1.1 criteria, as determined by the investigator, from the date of initial tumor response (CR or PR) to the date of first documented progressive disease (PD) or death from any cause, whichever occurs first.

Time frame
Throughout the study, up to approximately 2.5 years
3

Median progression free survival (PFS) per RECIST 1.1 criteria

PFS is defined as the time from the first dose of study treatment to the date of documented PD or death from any cause, whichever occurs first.

Time frame
Throughout the study, up to 2.5 years
4

Percent change from baseline in tumor size

Tumor size is defined as the sum of diameters of the target lesions.

Time frame
Throughout the study, up to 2.5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

MacroGenics

Lead sponsor

Source ClinicalTrials.gov
Apply now