TerminatedNCT03108495Updated Sep 25, 2026Results posted

Study of LN-145, Autologous Tumor Infiltrating Lymphocytes in the Treatment of Patients With Cervical Carcinoma

A Phase 2 interventional study of LN-145 and LN-145 + pembrolizumab in Cervical Carcinoma, sponsored by Iovance Biotherapeutics, Inc.. Terminated at 43 sites in 8 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Iovance Biotherapeutics, Inc. · Phase 2, Interventional, and Treatment

Why this study was terminated

After reviewing available safety and efficacy data to date, Iovance concluded the study reached the required number of events for evaluation of study endpoints.

Updated Sep 25, 2026Posted results revisedPrimary outcomes revisedGo to Updates ↓

Phase: Phase 2
Study type: Interventional
Enrollment: 210
Allocation: Non-randomized
Ages: 18 Years and older
Sex: Female

Study summary

Prospective, multicenter, multiple cohort, open label, interventional study evaluating adoptive cell therapy (ACT) with autologous tumor infiltrating lymphocytes (TIL) infusion (LN-145), with or without pembrolizumab, followed by IL-2 after a non-myeloablative lymphodepletion (NMA-LD) preparative regimen for the treatment of participants with recurrent, metastatic, or persistent cervical carcinoma.

Read the detailed description

LN-145 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process, as originally developed by the NCI, for the treatment of participants with recurrent, metastatic, or persistent cervical carcinoma. The cell transfer therapy used in this study involves participants receiving a non-myeloablative lymphodepletion (NMA-LD) preparative regimen, followed by infusion of autologous TIL, with or without pembrolizumab, followed by the administration of a regimen of IL-2.

Conditions studied

Cervical Carcinoma

Browse trials for

Uterine Cervical Neoplasms 1,881

Keywords

LN-145
Cell Therapy
Autologous Adoptive Cell Transfer
Autologous Adoptive Cell Therapy
Cellular Immuno-therapy
Tumor Infiltrating Lymphocytes
TIL
IL-2
Pembrolizumab

In context

Uterine Cervical Neoplasms

1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.

This study's enrollment of 210 is above the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

Iovance Biotherapeutics, Inc. is the lead sponsor of 16 studies on the registry; 8 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Female
Accepts healthy volunteers: No

Inclusion criteria

To be eligible for the study, participants must meet ALL of the following criteria prior to participation:

Must be ≥ 18 years of age at the time of consent. Enrollment of participants > 70 years of age may be allowed after consultation with the Medical Monitor.
Must have recurrent, metastatic, or persistent squamous cell carcinoma (SCC), adenosquamous carcinoma (ASC), or adenocarcinoma (AC) of the cervix that is not amenable to curative treatment with surgery and/or radiation therapy.
At least one resectable lesion (or aggregate of lesions resected) of a minimum 1.5 cm in diameter post-resection to generate TIL; surgical removal with minimal morbidity (defined as any procedure for which expected hospitalization is ≤ 3 days)
At least one measurable target lesion, as defined by RECIST v1.1.
Cohort 1 and Cohort 2: Progression during or following at least one, but no more than three, prior systemic chemotherapeutic treatments for recurrent, metastatic, or persistent cervical carcinoma
- A line of systemic therapy is defined as any chemotherapy or multiple-agent chemotherapy regimen that was administered for recurrent, metastatic, or persistent SCC, ASC, or AC of the cervix.
- A bevacizumab and chemotherapy combination is encouraged as a prior line of treatment.
- Neither chemoradiation, nor chemotherapy in the neoadjuvant or adjuvant settings are considered as a prior line of systemic therapy.
Cohort 2: Must also have previously received treatment with a checkpoint inhibitor (ie, PD-1, PD-L1]) in the setting of recurrent, metastatic, or persistent disease either as monotherapy or in combination (eg, in combination with chemotherapy or another immune agent)
Cohort 3 (United States only): Must have not received any therapies other than prior chemoradiation or surgery for loco-regional disease
Any prior therapy directed at the malignant tumor, including chemotherapy, biologic/targeted agents, and immunologic agents must be discontinued at least 28 days prior to tumor resection.
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Must have adequate organ function.
Participant has no evidence of any active viral, bacterial, or fungal infection requiring ongoing systemic treatment. Participants must be seronegative for the human immunodeficiency virus (HIV). Participants with acute or chronic hepatitis infections may be enrolled if the viral load by nucleic acid amplification test (NAAT) is undetectable with/without active treatment
Participants of childbearing potential must be willing to take the appropriate precaution to avoid pregnancy for the duration of the study and practice an approved, highly effective method of birth control during treatment and for 12 months after receiving the last protocol-related therapy.
Prior to study Enrollment (tumor resection), participant must have documentation of radiological disease progression after the most recent therapy

Exclusion criteria

Exclusion Criteria:

Participants who meet any of the following criteria are not eligible for participation in this study:

Participants who have received an organ allograft or prior cell transfer therapy except for prior LN-145 therapy in the setting of re-treatment only.
Participants who require ongoing systemic steroid therapy (> 10 mg/day of prednisone or other steroid equivalent dose).
Participants who currently have prior therapy-related toxicities Grade > 1 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0; except for peripheral neuropathy, alopecia, or vitiligo prior to Enrollment (tumor resection).
. Participants who have a history of hypersensitivity to any component or excipient of LN-145 or other study drugs:
- NMA-LD preparative regimen (cyclophosphamide, mesna, and fludarabine)
Participants who have active systemic infections, coagulation disorders, or other active major medical illness(es) of the cardiovascular, respiratory, or immune system, including evidence in the medical history of urinary tract obstruction, a positive cardiac stress test, myocardial infarction, cardiac arrhythmia, obstructive or restrictive pulmonary disease, or other conditions that in the opinion of the Investigator would increase the risk of participation.
Participants with symptomatic and/or untreated brain metastases (of any size and any number)
- Participants with definitively treated brain metastases may be considered for Enrollment, and must be stable for ≥ 14 days prior to beginning the NMA-LD preparative regimen
Participants who have any form of primary immunodeficiency (such as severe combined immunodeficiency [SCID] or acquired immunodeficiency syndrome [AIDS])
Participants who have a diagnosis of end-stage renal disorder requiring hemodialysis
Participants who have a left ventricular ejection fraction (LVEF) \< 45% or who are New York Heart Association (NYHA) Class 2 or higher.
Participants who have a documented forced expiratory volume in 1 second (FEV1) of ≤ 60%
Participants who have had another primary malignancy within the previous 3 years (except for curatively treated localized malignancy that has not required treatment for > 1 year, and in the judgement of the Investigator, does not pose a significant risk of recurrence including, but not limited to, non-melanoma skin cancer or bladder cancer)
Participants who are of the following protected classes will be excluded, including:
- Pregnant, parturient, or breastfeeding women
- Persons who are hospitalized without consent or those deprived of liberty because of a judiciary or administrative decision
- Participants with a legal protection measure or a person who cannot express his/her consent
- Participants in emergency situations who cannot consent to the study
Participants who have received a live or attenuated vaccine within 28 days prior to beginning the NMA-LD preparative regimen
Participants whose cancer requires immediate attention or who would otherwise suffer a disadvantage by participating in this study
Cohort 1 and Cohort 3: Participants who have received prior treatment with immunotherapy (eg, PD-1, PD-L1, or anti-cytotoxic T lymphocyte-associated antigen-4 [CTLA-4] antibodies)
Participants who have Grade ≥ 2 hemorrhage within 14 days prior to Enrollment (tumor resection)
Cohort 3: Participants may not have active or prior documented autoimmune or inflammatory disorders (including pneumonitis, inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]).

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 210 participants (actual)

Study arms

Experimental
Cohort 1 LN-145 monotherapy
LN-145 monotherapy in participants who have progressed during or following systemic therapy; this cohort is no longer open for enrollment.
Biological: LN-145
Experimental
Cohort 2 LN-145 monotherapy
LN-145 monotherapy in participants who have previously received a PD-1/PD-L1 checkpoint inhibitor either as monotherapy or combination therapy.
Biological: LN-145
Experimental
Cohort 3 - Combination Arm (TIL + Pembrolizumab) - US Only
LN-145 in combination with pembrolizumab in participants who have not received any therapies other than prior chemoradiation or surgery for loco-regional disease.
Biological: LN-145 + pembrolizumab
Experimental
Cohort 4 - Previously Enrolled Cohort
LN-145 monotherapy in previously enrolled participants who do not meet requirements for inclusion in the other study cohorts; this cohort is not open for enrollment.
Biological: LN-145
Experimental
Cohort 5 Retreatment Cohort
LN-145 monotherapy as a re-treatment.
Biological: LN-145

Interventions

BiologicalLN-145
A tumor sample is resected from each participant and cultured ex vivo to expand the population of tumor infiltrating lymphocytes.
Also known as: TIL, autologous tumor infiltrating lymphocytes
BiologicalLN-145 + pembrolizumab
A tumor sample is resected from each participant and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. The first dose of anti-PD-1 immunotherapy will be administered following tumor resection.
Also known as: TIL, autologous tumor infiltrating lymphocytes; pembrolizumab (anti-PD-1 immunotherapy)

What researchers measure

Primary outcomes

Cohort 1 and 2: Objective Response Rate
To evaluate the efficacy of LN-145 in participants with recurrent, metastatic, or persistent cervical carcinoma based on the objective response rate (ORR) as assessed by the Investigator per Response Evaluation Criteria In Solid Tumors (RECIST v1.1) for target lesions based on imaging: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: Up to 60 months
Cohort 3: Number of Participants With Adverse Events
To characterize the safety profile of LN-145 in combination with pembrolizumab in participants with recurrent, metastatic, or persistent cervical carcinoma as assessed by number of participants with adverse events.
Time frame: Up to 60 months
Cohort 4: Number of Participants With Adverse Events
To explore the safety profile of LN-145 in previously enrolled participants with recurrent, metastatic, or persistent cervical carcinoma as assessed by number of participants with adverse events.
Time frame: Up to 60 months
Cohort 4: Efficacy/Objective Response Rate
To explore the efficacy of LN-145 in previously enrolled participants with recurrent, metastatic, or persistent cervical carcinoma based on the objective response rate (ORR) as assessed by the Investigator per Response Evaluation Criteria In Solid Tumors (RECIST v1.1) for target lesions based on imaging: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: Up to 60 months
Cohort 5: Number of Participants With Adverse Events
To explore the safety profile of LN-145 in re-treated participants with recurrent, metastatic, or persistent cervical carcinoma as assessed by number of participants with adverse events.
Time frame: Up to 60 months
Cohort 5: Efficacy/Objective Response Rate
To explore the efficacy of LN-145 in re-treated participants with recurrent, metastatic, or persistent cervical carcinoma based on the objective response rate (ORR) as assessed by the Investigator per Response Evaluation Criteria In Solid Tumors (RECIST v1.1) for target lesions based on imaging: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: Up to 60 months

Secondary outcomes

Cohort 1 and 2: Duration of Response
To evaluate the efficacy parameters of LN-145 in participants with recurrent, metastatic, or persistent cervical carcinoma by assessing duration of response (DOR) as assessed by the Investigator per Response Evaluation Criteria In Solid Tumors (RECIST v1.1) for target lesions based on imaging: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. DOR is measured from the first time response (PR/CR) criteria are met until the first date of progression, or the participant expires.
Time frame: Up to 60 months
Cohort 1 and 2: Disease Control Rate
To evaluate the efficacy parameters of LN-145 in participants with recurrent, metastatic, or persistent cervical carcinoma by assessing disease control rate (DCR) as assessed by the Investigator per Response Evaluation Criteria In Solid Tumors (RECIST v1.1) for target lesions based on imaging: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), \<20% increase nadir SLD (sum of longest diameter of target lesions). DCR is defined as the proportion of participants who have CR or PR or SD per RECIST v1.1.
Time frame: Up to 60 months
Cohort 1 and 2: Progression-Free Survival
To evaluate the efficacy parameters of LN-145 in participants with recurrent, metastatic, or persistent cervical carcinoma by assessing progression-free survival (PFS) as assessed by the Investigator per Response Evaluation Criteria In Solid Tumors (RECIST v1.1). Progression is defined using RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: Up to 60 months
Cohort 1 and 2: Overall Survival
To evaluate overall survival (OS) in participants with recurrent, metastatic, or persistent cervical carcinoma
Time frame: Up to 60 months
Cohort 1 and 2: Number of Participants With Adverse Events
To characterize the safety profile of LN-145 in participants with recurrent, metastatic, or persistent cervical carcinoma as assessed by number of participants with adverse events.
Time frame: Up to 60 months
Cohort 3: Objective Response Rate
To evaluate the efficacy of LN-145 in combination with pembrolizumab in participants with recurrent, metastatic, or persistent cervical carcinoma based on the objective response rate (ORR) as assessed by the Investigator per Response Evaluation Criteria In Solid Tumors (RECIST v1.1) for target lesions based on imaging: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: Up to 60 months
Cohort 3: Duration of Response
To evaluate the efficacy of LN-145 in combination with pembrolizumab in participants with recurrent, metastatic, or persistent cervical carcinoma by assessing duration of response (DOR) as assessed by the Investigator per Response Evaluation Criteria In Solid Tumors (RECIST v1.1) for target lesions based on imaging: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. DOR is measured from the first time response (PR/CR) criteria are met until the first date of progression, or the participant expires.
Time frame: Up to 60 months
Cohort 3: Disease Control Rate
To evaluate the efficacy of LN-145 in combination with pembrolizumab in participants with recurrent, metastatic, or persistent cervical carcinoma by assessing disease control rate (DCR) as assessed by the Investigator per Response Evaluation Criteria In Solid Tumors (RECIST v1.1) for target lesions based on imaging: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), \<20% increase nadir SLD (sum of longest diameter of target lesions). DCR is defined as the proportion of participants who have CR or PR or SD per RECIST v1.1.
Time frame: Up to 60 months
Cohort 3: Progression-Free Survival
To evaluate the efficacy of LN-145 in combination with pembrolizumab in participants with recurrent, metastatic, or persistent cervical carcinoma by assessing progression-free survival (PFS) as assessed by the Investigator per Response Evaluation Criteria In Solid Tumors (RECIST v1.1). Progression is defined using RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: Up to 60 months
Cohort 3: Overall Survival
To evaluate overall survival (OS) in participants with recurrent, metastatic, or persistent cervical carcinoma.
Time frame: Up to 60 months

Results

Posted Jul 31, 2026

Participant flow

Initial Treatment

Participant flow — Initial Treatment
Milestone	Cohort 1	Cohort 2	Cohort 3	Cohort 4
Started	100	62	32	16
Participants infused with til	74	42	26	10
Completed	7	0	1	1
Not completed	93	62	31	15
Withdrew: Did not receive til	26	20	6	6
Withdrew: Death	63	34	17	9
Withdrew: Lost to follow-up	2	3	0	0
Withdrew: Withdrawal by subject	2	4	1	0
Withdrew: Study terminated by sponsor	0	1	7	0

Retreatment

Participant flow — Retreatment
Milestone	Cohort 1	Cohort 2	Cohort 3	Cohort 4	Cohort 5
Started	0	0	0	0	6
Participants infused with til	0	0	0	0	2
Completed	0	0	0	0	0
Not completed	0	0	0	0	6
Withdrew: Did not receive til	0	0	0	0	4
Withdrew: Death	0	0	0	0	2

Outcome measures

PrimaryCohort 1 and 2: Objective Response Rate

To evaluate the efficacy of LN-145 in participants with recurrent, metastatic, or persistent cervical carcinoma based on the objective response rate (ORR) as assessed by the Investigator per Response Evaluation Criteria In Solid Tumors (RECIST v1.1) for target lesions based on imaging: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Time frame:: Up to 60 months
Reported as:: Count of participants · Participants

Cohort 1 and 2: Objective Response Rate
Participants	Cohort 1	Cohort 2
Cohort 1 and 2: Objective Response Rate	15	5

PrimaryCohort 3: Number of Participants With Adverse Events

To characterize the safety profile of LN-145 in combination with pembrolizumab in participants with recurrent, metastatic, or persistent cervical carcinoma as assessed by number of participants with adverse events.

Time frame:: Up to 60 months
Reported as:: Count of participants · Participants

Cohort 3: Number of Participants With Adverse Events
Participants	Cohort 3
Cohort 3: Number of Participants With Adverse Events	26

PrimaryCohort 4: Number of Participants With Adverse Events

To explore the safety profile of LN-145 in previously enrolled participants with recurrent, metastatic, or persistent cervical carcinoma as assessed by number of participants with adverse events.

Time frame:: Up to 60 months
Reported as:: Count of participants · Participants

Cohort 4: Number of Participants With Adverse Events
Participants	Cohort 4
Cohort 4: Number of Participants With Adverse Events	10

PrimaryCohort 4: Efficacy/Objective Response Rate

To explore the efficacy of LN-145 in previously enrolled participants with recurrent, metastatic, or persistent cervical carcinoma based on the objective response rate (ORR) as assessed by the Investigator per Response Evaluation Criteria In Solid Tumors (RECIST v1.1) for target lesions based on imaging: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Time frame:: Up to 60 months
Reported as:: Count of participants · Participants

Cohort 4: Efficacy/Objective Response Rate
Participants	Cohort 4
Cohort 4: Efficacy/Objective Response Rate	2

PrimaryCohort 5: Number of Participants With Adverse Events

To explore the safety profile of LN-145 in re-treated participants with recurrent, metastatic, or persistent cervical carcinoma as assessed by number of participants with adverse events.

Time frame:: Up to 60 months
Reported as:: Count of participants · Participants

Cohort 5: Number of Participants With Adverse Events
Participants	Cohort 5
Cohort 5: Number of Participants With Adverse Events	2

PrimaryCohort 5: Efficacy/Objective Response Rate

To explore the efficacy of LN-145 in re-treated participants with recurrent, metastatic, or persistent cervical carcinoma based on the objective response rate (ORR) as assessed by the Investigator per Response Evaluation Criteria In Solid Tumors (RECIST v1.1) for target lesions based on imaging: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Time frame:: Up to 60 months
Reported as:: Count of participants · Participants

Cohort 5: Efficacy/Objective Response Rate
Participants	Cohort 5
Cohort 5: Efficacy/Objective Response Rate	0

SecondaryCohort 1 and 2: Duration of Response

To evaluate the efficacy parameters of LN-145 in participants with recurrent, metastatic, or persistent cervical carcinoma by assessing duration of response (DOR) as assessed by the Investigator per Response Evaluation Criteria In Solid Tumors (RECIST v1.1) for target lesions based on imaging: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. DOR is measured from the first time response (PR/CR) criteria are met until the first date of progression, or the participant expires.

Time frame:: Up to 60 months
Reported as:: Median · months

Cohort 1 and 2: Duration of Response
months	Cohort 1	Cohort 2
Cohort 1 and 2: Duration of Response	6.8 (2.5 to NA)	6.7 (4.2 to NA)

SecondaryCohort 1 and 2: Disease Control Rate

To evaluate the efficacy parameters of LN-145 in participants with recurrent, metastatic, or persistent cervical carcinoma by assessing disease control rate (DCR) as assessed by the Investigator per Response Evaluation Criteria In Solid Tumors (RECIST v1.1) for target lesions based on imaging: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), \<20% increase nadir SLD (sum of longest diameter of target lesions). DCR is defined as the proportion of participants who have CR or PR or SD per RECIST v1.1.

Time frame:: Up to 60 months
Reported as:: Count of participants · Participants

Cohort 1 and 2: Disease Control Rate
Participants	Cohort 1	Cohort 2
Cohort 1 and 2: Disease Control Rate	43	23

SecondaryCohort 1 and 2: Progression-Free Survival

To evaluate the efficacy parameters of LN-145 in participants with recurrent, metastatic, or persistent cervical carcinoma by assessing progression-free survival (PFS) as assessed by the Investigator per Response Evaluation Criteria In Solid Tumors (RECIST v1.1). Progression is defined using RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Time frame:: Up to 60 months
Reported as:: Median · months

Cohort 1 and 2: Progression-Free Survival
months	Cohort 1	Cohort 2
Cohort 1 and 2: Progression-Free Survival	2.8 (2.3 to 4.1)	2.8 (1.5 to 2.9)

SecondaryCohort 1 and 2: Overall Survival

To evaluate overall survival (OS) in participants with recurrent, metastatic, or persistent cervical carcinoma

Time frame:: Up to 60 months
Reported as:: Median · months

Cohort 1 and 2: Overall Survival
months	Cohort 1	Cohort 2
Cohort 1 and 2: Overall Survival	8.8 (6.7 to 11.4)	8.2 (4.0 to 10.3)

SecondaryCohort 1 and 2: Number of Participants With Adverse Events

To characterize the safety profile of LN-145 in participants with recurrent, metastatic, or persistent cervical carcinoma as assessed by number of participants with adverse events.

Time frame:: Up to 60 months
Reported as:: Count of participants · Participants

Cohort 1 and 2: Number of Participants With Adverse Events
Participants	Cohort 1	Cohort 2
Cohort 1 and 2: Number of Participants With Adverse Events	74	42

SecondaryCohort 3: Objective Response Rate

To evaluate the efficacy of LN-145 in combination with pembrolizumab in participants with recurrent, metastatic, or persistent cervical carcinoma based on the objective response rate (ORR) as assessed by the Investigator per Response Evaluation Criteria In Solid Tumors (RECIST v1.1) for target lesions based on imaging: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Time frame:: Up to 60 months
Reported as:: Count of participants · Participants

Cohort 3: Objective Response Rate
Participants	Cohort 3
Cohort 3: Objective Response Rate	13

SecondaryCohort 3: Duration of Response

To evaluate the efficacy of LN-145 in combination with pembrolizumab in participants with recurrent, metastatic, or persistent cervical carcinoma by assessing duration of response (DOR) as assessed by the Investigator per Response Evaluation Criteria In Solid Tumors (RECIST v1.1) for target lesions based on imaging: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. DOR is measured from the first time response (PR/CR) criteria are met until the first date of progression, or the participant expires.

Time frame:: Up to 60 months
Reported as:: Median · months

Cohort 3: Duration of Response
months	Cohort 3
Cohort 3: Duration of Response	NA (4.4 to NA)

SecondaryCohort 3: Disease Control Rate

To evaluate the efficacy of LN-145 in combination with pembrolizumab in participants with recurrent, metastatic, or persistent cervical carcinoma by assessing disease control rate (DCR) as assessed by the Investigator per Response Evaluation Criteria In Solid Tumors (RECIST v1.1) for target lesions based on imaging: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), \<20% increase nadir SLD (sum of longest diameter of target lesions). DCR is defined as the proportion of participants who have CR or PR or SD per RECIST v1.1.

Time frame:: Up to 60 months
Reported as:: Count of participants · Participants

Cohort 3: Disease Control Rate
Participants	Cohort 3
Cohort 3: Disease Control Rate	23

SecondaryCohort 3: Progression-Free Survival

To evaluate the efficacy of LN-145 in combination with pembrolizumab in participants with recurrent, metastatic, or persistent cervical carcinoma by assessing progression-free survival (PFS) as assessed by the Investigator per Response Evaluation Criteria In Solid Tumors (RECIST v1.1). Progression is defined using RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Time frame:: Up to 60 months
Reported as:: Median · months

Cohort 3: Progression-Free Survival
months	Cohort 3
Cohort 3: Progression-Free Survival	6.2 (3.3 to NA)

SecondaryCohort 3: Overall Survival

To evaluate overall survival (OS) in participants with recurrent, metastatic, or persistent cervical carcinoma.

Time frame:: Up to 60 months
Reported as:: Median · months

Cohort 3: Overall Survival
months	Cohort 3
Cohort 3: Overall Survival	27.7 (15.2 to 41.6)

Adverse events

Collected over From enrollment to end of follow-up (up to 60 months). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Cohort 1	63/74 (85.1%)	31/74 (41.9%)	74/74 (100%)
Cohort 2	34/42 (81%)	20/42 (47.6%)	42/42 (100%)
Cohort 3	17/26 (65.4%)	18/26 (69.2%)	26/26 (100%)
Cohort 4	9/10 (90%)	7/10 (70%)	10/10 (100%)
Cohort 5	2/2 (100%)	1/2 (50%)	2/2 (100%)

Most frequent serious events

Showing 10 of 88

Most frequent serious events
Event	Cohort 1	Cohort 2	Cohort 3	Cohort 4	Cohort 5
NauseaGastrointestinal disorders	0/74	0/42	1/26	0/10	1/2
VomitingGastrointestinal disorders	1/74	0/42	2/26	1/10	1/2
DehydrationMetabolism and nutrition disorders	1/74	0/42	0/26	0/10	1/2
Acute kidney injuryRenal and urinary disorders	4/74	6/42	2/26	0/10	0/2
Respiratory failureRespiratory, thoracic and mediastinal disorders	0/74	1/42	3/26	0/10	0/2
ThrombocytopeniaBlood and lymphatic system disorders	4/74	3/42	0/26	1/10	0/2
Acute myocardial infarctionCardiac disorders	0/74	0/42	0/26	1/10	0/2
Cardiac failure congestiveCardiac disorders	0/74	0/42	0/26	1/10	0/2
Ventricular fibrillationCardiac disorders	0/74	0/42	0/26	1/10	0/2
Systemic inflammatory response syndromeGeneral disorders	0/74	0/42	0/26	1/10	0/2

Most frequent other events

Showing 10 of 398

Most frequent other events
Event	Cohort 1	Cohort 2	Cohort 3	Cohort 4	Cohort 5
ChillsGeneral disorders	45/74	25/42	23/26	5/10	0/2
NauseaGastrointestinal disorders	19/74	3/42	22/26	1/10	0/2
AnaemiaBlood and lymphatic system disorders	49/74	24/42	20/26	7/10	1/2
ThrombocytopeniaBlood and lymphatic system disorders	39/74	26/42	15/26	7/10	1/2
VomitingGastrointestinal disorders	22/74	9/42	18/26	3/10	1/2
FatigueGeneral disorders	16/74	5/42	17/26	2/10	0/2
NeutropeniaBlood and lymphatic system disorders	26/74	7/42	14/26	6/10	0/2
PyrexiaGeneral disorders	41/74	13/42	14/26	6/10	0/2
ConstipationGastrointestinal disorders	9/74	5/42	15/26	0/10	1/2
HypoxiaRespiratory, thoracic and mediastinal disorders	20/74	6/42	15/26	2/10	0/2

Baseline characteristics

The Safety Analysis Set is defined as participants who received TIL. Cohort 5 participants had progressed following the initial TIL treatment in Cohorts 1 or 2, and then were retreated with a second TIL treatment. Data are captured for retreatment in Cohort 5.

Age, Categorical
Age, Categorical(Participants)	Cohort 1	Cohort 2	Cohort 3	Cohort 4	Cohort 5	Total
Initial Treatment — <=18 years	0	1	0	0	0	1
Initial Treatment — Between 18 and 65 years	69	37	23	10	0	139
Initial Treatment — >=65 years	5	4	3	0	0	12
Retreatment — <=18 years	0	0	0	0	0	0
Retreatment — Between 18 and 65 years	0	0	0	0	2	2
Retreatment — >=65 years	0	0	0	0	0	0

Age, Continuous
Age, Continuous(Years)	Cohort 1	Cohort 2	Cohort 3	Cohort 4	Cohort 5	Total
Initial Treatment	44 (24 to 72)	46.5 (18 to 72)	46.5 (31 to 73)	46.5 (38 to 61)	—	45 (18 to 73)
Retreatment	—	—	—	—	49.5 (43 to 56)	49.5 (43 to 56)

Sex: Female, Male
Sex: Female, Male(Participants)	Cohort 1	Cohort 2	Cohort 3	Cohort 4	Cohort 5	Total
Initial Treatment — Female	74	42	26	10	0	152
Initial Treatment — Male	0	0	0	0	0	0
Retreatment — Female	—	—	—	—	2	2
Retreatment — Male	—	—	—	—	0	0

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Cohort 1	Cohort 2	Cohort 3	Cohort 4	Cohort 5	Total
Initial Treatment — Hispanic or Latino	5	7	4	1	0	17
Initial Treatment — Not Hispanic or Latino	60	35	22	7	0	124
Initial Treatment — Unknown or Not Reported	9	0	0	2	0	11
Retreatment — Hispanic or Latino	0	0	0	0	0	0
Retreatment — Not Hispanic or Latino	0	0	0	0	2	2
Retreatment — Unknown or Not Reported	0	0	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Cohort 1	Cohort 2	Cohort 3	Cohort 4	Cohort 5	Total
Initial Treatment — American Indian or Alaska Native	0	0	0	0	0	0
Initial Treatment — Asian	4	2	3	0	0	9
Initial Treatment — Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0
Initial Treatment — Black or African American	2	3	0	0	0	5
Initial Treatment — White	58	33	23	9	0	123
Initial Treatment — More than one race	0	0	0	0	0	0
Initial Treatment — Unknown or Not Reported	10	4	0	1	0	15
Retreatment — American Indian or Alaska Native	0	0	0	0	0	0
Retreatment — Asian	0	0	0	0	0	0
Retreatment — Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0
Retreatment — Black or African American	0	0	0	0	0	0
Retreatment — White	0	0	0	0	2	2
Retreatment — More than one race	0	0	0	0	0	0
Retreatment — Unknown or Not Reported	0	0	0	0	0	0

Region of Enrollment
Region of Enrollment(Participants)	Cohort 1	Cohort 2	Cohort 3	Cohort 4	Total
Netherlands	8	0	0	0	8
United States	40	35	26	9	110
United Kingdom	7	0	0	0	7
France	4	0	0	1	5
Switzerland	3	1	0	0	4
Germany	6	1	0	0	7
Spain	6	5	0	0	11

Region of Enrollment
Region of Enrollment(Participants)	Cohort 1	Cohort 2	Cohort 3	Cohort 4	Cohort 5	Total
United States	—	—	—	—	1	1
Switzerland	—	—	—	—	1	1

Study locations

43 sites

St. Joseph's Hospital and Medical Center Center For Women's Health
Phoenix, Arizona 85013, United States
University of Southern California
Los Angeles, California 90033, United States
University of California San Diego
San Diego, California 92093, United States
Sylvester Comprehensive Cancer Center
Miami, Florida 33136, United States
University of Florida Health Cancer Center
Orlando, Florida 32806, United States
University of South Florida H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida 33612, United States
Augusta University
Augusta, Georgia 30912-0003, United States
University of Chicago
Chicago, Illinois 60637, United States
James Graham Brown Cancer Center
Louisville, Kentucky 40202, United States
LSU Health Sciences Center
New Orleans, Louisiana 70112, United States
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland 21287-0013, United States
Dana Farber Cancer Institute
Boston, Massachusetts 02215, United States
Karmanos Cancer Institute
Detroit, Michigan 48201, United States
Rutgers University
Newark, New Jersey 07103, United States
Roswell Park Cancer Institute
Buffalo, New York 14263, United States
Cleveland Clinic
Cleveland, Ohio 44195, United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104, United States
Allegheny Health
Pittsburgh, Pennsylvania 15224, United States
UPMC Cancer Center
Pittsburgh, Pennsylvania 15232, United States
Avera Medical Group Oncology
Sioux Falls, South Dakota 57105, United States
MD Anderson Cancer Center
Houston, Texas 77030, United States
University of Virginia
Charlottesville, Virginia 22908, United States
Medical College of Wisconsin
Milwaukee, Wisconsin 53225, United States
Centre Hospitalier Lyon Sud
Pierre-Bénite, Auvergne-Rhône-Alpes 69495, France
Centre Léon Bérard
Lyon, 69008, France
Gustave Roussy Cancer Campus
Villejuif, 94805, France
Universitätsklinikum Erlangen
Erlangen, Bavaria 91054, Germany
Universitätsklinikum Carl Gustav Carus
Dresden, Saxony 01307, Germany
Istituto Europeo di Oncologia
Miano, Milano 20141, Italy
Academisch Medisch Centrum
Amsterdam, AZ 1105, Netherlands
Clínica Universidad de Navarra
Pamplona, Navarre 31008, Spain
Hospital Universitari Vall d'Hebrón
Barcelona, 08035, Spain
Institut Català d'Oncologia
Barcelona, 08908, Spain
Hospital General Universitario Gregorio Marañon
Madrid, 28007, Spain
Hospital Universitario Madrid Sanchinarro
Madrid, 28050, Spain
Inselspital
Bern, CH-3010, Switzerland
Centre Hospitalier Universitaire Vaudois Lausanne - Centre Pluridisciplinaire d'Oncologie
Lausanne, Switzerland
Bristol Haematology and Oncology Centre
Bristol, England BS2 8ED, United Kingdom
Sarah Cannon Research Institute London
London, England W1G 6AD, United Kingdom
University College London Hospitals NHS Foundation Trust
London, England W1G 6BW, United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, Scotland G12 0YN, United Kingdom
Guy's & St.Thomas NHS Foundation Trust
London, SE1 9RT, United Kingdom

References and documents

Study documents

Study protocol · Aug 14, 2025
Statistical analysis plan · Dec 10, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

1 registry update since Sep 25, 2026

Results

Posted results revised

revised Sep 25, 2026

Also revised

primary outcomes

Show all 1 update

Sep 25, 2026
Posted results revised
Primary outcomes Revised (9 changes)
+ 2 other changes: verification date and secondary outcomes

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03108495
Lead sponsor: Iovance Biotherapeutics, Inc.
Responsible party: Sponsor
First posted: Apr 11, 2017
Start date: Jun 22, 2017
Primary completion: Aug 22, 2025
Completion: Aug 22, 2025
Results posted: Jul 31, 2026
Last update: Sep 25, 2026

Study contacts

Iovance Medical Monitor

study director · Iovance Biotherapeutics, Inc.

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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