TIL Therapy for Cervical Cancer

Recruiting in Palo Alto (17 mi)

+42 other locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Iovance Biotherapeutics, Inc.

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

Prospective, multicenter, single-arm, open label, interventional study evaluating adoptive cell therapy (ACT) with autologous tumor infiltrating lymphocytes (TIL) infusion (LN-145) followed by IL-2 after a non-myeloablative (NMA) lymphodepletion preparative regimen for the treatment of patients with recurrent, metastatic, or persistent cervical carcinoma

Eligibility Criteria

Adults over 18 with recurrent, metastatic, or persistent cervical cancer not treatable by surgery/radiation. Must have measurable lesions and be in good physical condition (ECOG 0-1). Previous systemic therapy is required; however, no more than three lines of chemotherapy for Cohorts 1 and 2. Participants must have adequate organ function, no active infections or HIV, and agree to contraception.

Inclusion Criteria

I have received bevacizumab and chemotherapy together before.

I have a tumor that can be surgically removed and is at least 1.5 cm wide.

At least one measurable target lesion, as defined by RECIST v1.1.

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Exclusion Criteria

I am receiving a specific chemotherapy regimen before my transplant.

You have a condition that weakens your immune system, like severe combined immunodeficiency (SCID) or acquired immunodeficiency syndrome (AIDS).

My heart's pumping ability is below normal, or I have moderate to severe heart problems.

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Treatment Details

Interventions

LN-145 (CAR T-cell Therapy)
Pembrolizumab (Monoclonal Antibodies)

Trial OverviewThe trial studies LN-145 alone or combined with pembrolizumab in treating cervical carcinoma. It's a prospective study where patients receive TIL infusion after lymphodepletion. The goal is to evaluate the effectiveness of this adoptive cell therapy for those who've had previous treatments but still show disease progression.

Participant Groups

5Treatment groups

Experimental Treatment

Group I: Cohort 5 Retreatment CohortExperimental Treatment1 Intervention

Patients who have been previously treated with LN-145 may be given a second treatment with TIL.

Group II: Cohort 4 - Non-enrolling CohortExperimental Treatment1 Intervention

Cohort includes patient population not meeting inclusion criteria in cohort 1 and 2. Post-NMA lymphodepletion, patients are infused with their autologous TIL (LN-145) followed by IL-2 administration.

Group III: Cohort 3 - Combination Arm (TIL + Pembrolizumab) - US OnlyExperimental Treatment1 Intervention

Patients will be administered with pembrolizumab, followed by NMA lymphodepletion, then infused with their autologous TIL (LN-145) followed by pembrolizumab every 3 or 6 weeks post IL-2 administration up to 24 months.

Group IV: Cohort 2 LN-145 monotherapyExperimental Treatment1 Intervention

Patients previously treated with an antiprogrammed cell death protein-1 (PD-1) or anti-programmed death-ligand 1 (PD-L1) checkpoint inhibitor: Post-NMA lymphodepletion, patients are infused with their autologous TIL (LN-145) followed by IL-2 administration.

Group V: Cohort 1 LN-145 monotherapyExperimental Treatment1 Intervention

Post-NMA lymphodepletion, patients are infused with their autologous TIL (LN-145) followed by IL-2 administration.

LN-145 is already approved in United States for the following indications:

🇺🇸 Approved in United States as LN-145 for: