Cervical CarcinomaPhase 2NCT03108495
Study of LN-145, Autologous Tumor Infiltrating Lymphocytes in the Treatment of Patients With Cervical Carcinoma
A Phase 2 study testing LN-145 and LN-145 + pembrolizumab in people with Cervical Carcinoma, run by Iovance Biotherapeutics, Inc. at 43 sites in 8 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Carcinoma
- What is being tested?
- LN-145 and LN-145 + pembrolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 43 sitesin 8 countries
- Study dates
- 22 Jun 2017to 22 Aug 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 17Show fewer
- 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
Who cannot join
- 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)
Show all 24Show fewer
- 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.]).
Trial locations and contacts
43 sites in 8 countries.
43 sites in 8 countries
United States24 sites
Augusta University
Augusta, Georgia, 30912-0003
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287-0013
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Roswell Park Cancer Institute
Buffalo, New York, 14263
University of Virginia
Charlottesville, Virginia, 22908
University of Chicago
Chicago, Illinois, 60637
Cleveland Clinic
Cleveland, Ohio, 44195
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Karmanos Cancer Institute
Detroit, Michigan, 48201
MD Anderson Cancer Center
Houston, Texas, 77030
University of Southern California
Los Angeles, California, 90033
James Graham Brown Cancer Center
Louisville, Kentucky, 40202
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Medical College of Wisconsin
Milwaukee, Wisconsin, 53225
LSU Health Sciences Center
New Orleans, Louisiana, 70112
Rutgers University
Newark, New Jersey, 07103
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
University of Florida Health Cancer Center
Orlando, Florida, 32806
St. Joseph's Hospital and Medical Center Center For Women's Health
Phoenix, Arizona, 85013
Allegheny Health
Pittsburgh, Pennsylvania, 15224
UPMC Cancer Center
Pittsburgh, Pennsylvania, 15232
University of California San Diego
San Diego, California, 92093
Avera Medical Group Oncology
Sioux Falls, South Dakota, 57105
University of South Florida H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
Spain5 sites
Hospital Universitari Vall d'Hebrón
Barcelona, 08035
Institut Català d'Oncologia
Barcelona, 08908
Hospital General Universitario Gregorio Marañon
Madrid, 28007
Hospital Universitario Madrid Sanchinarro
Madrid, 28050
Clínica Universidad de Navarra
Pamplona, Navarre, 31008
United Kingdom5 sites
Bristol Haematology and Oncology Centre
Bristol, England, BS2 8ED
NHS Greater Glasgow and Clyde
Glasgow, Scotland, G12 0YN
Sarah Cannon Research Institute London
London, England, W1G 6AD
University College London Hospitals NHS Foundation Trust
London, England, W1G 6BW
Guy's & St.Thomas NHS Foundation Trust
London, SE1 9RT
France3 sites
Centre Léon Bérard
Lyon, 69008
Centre Hospitalier Lyon Sud
Pierre-Bénite, Auvergne-Rhône-Alpes, 69495
Gustave Roussy Cancer Campus
Villejuif, 94805
Germany2 sites
Universitätsklinikum Carl Gustav Carus
Dresden, Saxony, 01307
Universitätsklinikum Erlangen
Erlangen, Bavaria, 91054
Switzerland2 sites
Inselspital
Bern, CH-3010
Centre Hospitalier Universitaire Vaudois Lausanne - Centre Pluridisciplinaire d'Oncologie
Lausanne
About this study
Official title: A Phase 2, Multicenter Study to Evaluate the Efficacy and Safety Using Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients With Recurrent, Metastatic or Persistent Cervical Carcinoma
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
- Cervical Carcinoma
- Being tested
- LN-145, LN-145 + pembrolizumab
- Keywords
- LN-145, Cell Therapy, Autologous Adoptive Cell Transfer, Autologous Adoptive Cell Therapy, Cellular Immuno-therapy, Tumor Infiltrating Lymphocytes, TIL, IL-2, Pembrolizumab
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LN-145Biological
Also called TIL, autologous tumor infiltrating lymphocytes
A tumor sample is resected from each participant and cultured ex vivo to expand the population of tumor infiltrating lymphocytes.
LN-145 + pembrolizumabBiological
Also called TIL, autologous tumor infiltrating lymphocytes; pembrolizumab (anti-PD-1 immunotherapy)
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 LN-145 monotherapy | Experimental | LN-145 monotherapy in participants who have progressed during or following systemic therapy; this cohort is no longer open for enrollment. Receives: Biological: LN-145 |
| Cohort 2 LN-145 monotherapy | Experimental | LN-145 monotherapy in participants who have previously received a PD-1/PD-L1 checkpoint inhibitor either as monotherapy or combination therapy. Receives: Biological: LN-145 |
| Cohort 3 - Combination Arm (TIL + Pembrolizumab) - US Only | Experimental | LN-145 in combination with pembrolizumab in participants who have not received any therapies other than prior chemoradiation or surgery for loco-regional disease. Receives: Biological: LN-145 + pembrolizumab |
| Cohort 4 - Previously Enrolled Cohort | Experimental | 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. Receives: Biological: LN-145 |
| Cohort 5 Retreatment Cohort | Experimental | LN-145 monotherapy as a re-treatment. Receives: Biological: LN-145 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 60 months
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: Up to 60 months
Cohort 1 and 2: Overall Survival
To evaluate overall survival (OS) in participants with recurrent, metastatic, or persistent cervical carcinoma
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 60 months
Cohort 3: Overall Survival
To evaluate overall survival (OS) in participants with recurrent, metastatic, or persistent cervical carcinoma.
Measured: Up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start22 Jun 2017
- Primary completion22 Aug 2025
- Study completion22 Aug 2025
Why it stopped: After reviewing available safety and efficacy data to date, Iovance concluded the study reached the required number of events for evaluation of study endpoints.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervical CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iovance Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Iovance Medical Monitor, Study director, Iovance Biotherapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03108495
- Sponsor's protocol ID
- C-145-04
- Other IDs
- 2024-510634-41-00
- Status last verified
- Aug 2026
- First submitted
- 27 Mar 2017
- Last updated
- 25 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter Study to Evaluate the Efficacy and Safety Using Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients With Recurrent, Metastatic or Persistent Cervical Carcinoma
- ClinicalTrials.gov ID
- NCT03108495
- Acronym / sponsor ID
- C-145-04
- Conditions
- Cervical Carcinoma
- Keywords
- LN-145, Cell Therapy, Autologous Adoptive Cell Transfer, Autologous Adoptive Cell Therapy, Cellular Immuno-therapy, Tumor Infiltrating Lymphocytes, TIL, IL-2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: After reviewing available safety and efficacy data to date, Iovance concluded the study reached the required number of events for evaluation of study endpoints.
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Iovance Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Jun 2017 (actual)
- Primary completion
- 22 Aug 2025 (actual)
- Study completion
- 22 Aug 2025 (actual)
- First posted
- 11 Apr 2017 (actual)
- Results
- Posted 31 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 LN-145 monotherapy | Experimental | Biological: LN-145LN-145 monotherapy in participants who have progressed during or following systemic therapy; this cohort is no longer open for enrollment. |
| Cohort 2 LN-145 monotherapy | Experimental | Biological: LN-145LN-145 monotherapy in participants who have previously received a PD-1/PD-L1 checkpoint inhibitor either as monotherapy or combination therapy. |
| Cohort 3 - Combination Arm (TIL + Pembrolizumab) - US Only | Experimental | Biological: LN-145 + pembrolizumabLN-145 in combination with pembrolizumab in participants who have not received any therapies other than prior chemoradiation or surgery for loco-regional disease. |
| Cohort 4 - Previously Enrolled Cohort | Experimental | Biological: LN-145LN-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. |
| Cohort 5 Retreatment Cohort | Experimental | Biological: LN-145LN-145 monotherapy as a re-treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (24 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LN-145Also: TIL, autologous tumor infiltrating lymphocytesA tumor sample is resected from each participant and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. | Biological | Cohort 1 LN-145 monotherapy, Cohort 2 LN-145 monotherapy, Cohort 4 - Previously Enrolled Cohort, Cohort 5 Retreatment Cohort |
| LN-145 + pembrolizumabAlso: TIL, autologous tumor infiltrating lymphocytes; pembrolizumab (anti-PD-1 immunotherapy)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. | Biological | Cohort 3 - Combination Arm (TIL + Pembrolizumab) - US Only |
Primary outcome
Cohort 1 and 2: Objective Response Rate
Time frame: Up to 60 months
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.
Cohort 3: Number of Participants With Adverse Events
Time frame: Up to 60 months
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.
Cohort 4: Number of Participants With Adverse Events
Time frame: Up to 60 months
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.
Cohort 4: Efficacy/Objective Response Rate
Time frame: Up to 60 months
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.
Cohort 5: Number of Participants With Adverse Events
Time frame: Up to 60 months
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.
Cohort 5: Efficacy/Objective Response Rate
Time frame: Up to 60 months
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.
10 secondary outcomes
Cohort 1 and 2: Duration of Response
Time frame: Up to 60 months
Cohort 1 and 2: Disease Control Rate
Time frame: Up to 60 months
Cohort 1 and 2: Progression-Free Survival
Time frame: Up to 60 months
Cohort 1 and 2: Overall Survival
Time frame: Up to 60 months
Cohort 1 and 2: Number of Participants With Adverse Events
Time frame: Up to 60 months
Cohort 3: Objective Response Rate
Time frame: Up to 60 months
Cohort 3: Duration of Response
Time frame: Up to 60 months
Cohort 3: Disease Control Rate
Time frame: Up to 60 months
Cohort 3: Progression-Free Survival
Time frame: Up to 60 months
Cohort 3: Overall Survival
Time frame: Up to 60 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
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A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
RecruitingObservational study
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Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iovance Medical Monitor study director
Iovance Biotherapeutics, Inc.
43 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LN-145 and LN-145 + pembrolizumab in people with Cervical Carcinoma, run by Iovance Biotherapeutics, Inc. at 43 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States, Spain, United Kingdom, France, Germany and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohort 1 and 2: Objective Response Rate (time frame: Up to 60 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.