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LN-145 for Cervical Cancer

Universitätsklinikum Carl Gustav Carus, Dresden, Germany
Cervical CancerLN-145 - Biological
Eligibility
18+
Female
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Study Summary

This trial is testing a new cancer treatment that uses a patient's own immune cells to fight their cancer.

Eligible Conditions
  • Cervical Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Similar Trials

1
Cohort 1
1
TILT-123
1
CT-0508

Study Objectives

3 Primary · 11 Secondary · Reporting Duration: Up to 60 months

Up to 60 months
Cohort 1 and 2: Adverse Events
Cohort 1 and 2: Disease Control Rate
Cohort 1 and 2: Duration of Response
Cohort 1 and 2: Objective Response Rate
Cohort 1 and 2: Overall Survival
Cohort 1 and 2: Progression-Free Survival
Cohort 3: Adverse Events
Cohort 3: Disease Control Rate
Cohort 3: Duration of Response
Cohort 3: Objective Response Rate
Cohort 3: Overall Survival
Cohort 3: Progression-Free Survival
Cohort 4: Efficacy and Adverse Events
Cohort 5: Efficacy and Adverse Events

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Cohort 1
1
TILT-123
1
CT-0508

Side Effects for

Arm A (Phased Pembrolizumab Regimen)
71%Fatigue
43%Peripheral sensory neuropathy
38%Headache
38%Alopecia
33%Nausea
29%Hypothyroidism
29%Dyspnea
29%Cough
29%Pain
24%Constipation
24%Rash maculo-papular
19%Bloating
19%Dyspepsia
19%Infusion related reaction
19%Anorexia
19%Diarrhea
19%Abdominal pain
19%Pain in extremity
14%Anemia
14%Sinusitis
14%Hyperglycemia
14%Dehydration
14%Allergic rhinitis
14%Nasal congestion
14%Edema limbs
14%Hypokalemia
10%Dry mouth
10%Hyperthyroidism
10%Mucositis oral
10%Vomiting
10%Localized edema
10%Skin infection
10%Fall
10%Alanine aminotransferase increased
10%Neutrophil count decreased
10%Myalgia
10%Dizziness
10%Restlessness
10%Hoarseness
10%Pruritus
10%Lymphedema
10%Thromboembolic event
10%Pneumonitis
10%Hot flashes
10%Chills
10%Aspartate aminotransferase increased
10%Back pain
10%Flushing
5%Hypotension
5%Respiratory failure
5%Atrial flutter
5%Eye disorders - Other, specify
5%Hepatic failure
5%Lung infection
5%Malaise
5%Non-cardiac chest pain
5%Infections and infestations - Other, specify
5%Mucosal infection
5%Urinary tract infection
5%Bruising
5%Alkaline phosphatase increased
5%Hypophosphatemia
5%Metabolism and nutrition disorders - Other, specify
5%Dysgeusia
5%Recurrent laryngeal nerve palsy
5%Syncope
5%Urinary tract pain
5%Urinary urgency
5%Hypoxia
5%Postnasal drip
5%Sore throat
5%Skin hyperpigmentation
5%Fever
5%Hepatobiliary disorders - Other, specify
5%Upper respiratory infection
5%Blood bilirubin increased
5%Creatinine increased
5%Insomnia
5%Epistaxis
5%Laryngeal hemorrhage
5%Nail loss
5%Nail ridging
5%Lymph gland infection
5%Sneezing
5%Nail infection
5%Hypoglycemia
5%Urinary frequency
5%Urinary incontinence
5%Hypertension
5%Hyponatremia
5%Periorbital edema
5%Gastrointestinal disorders - Other
5%Platelet count decreased
5%Bone pain
5%Conjunctivitis
5%Flashing lights
5%Allergic reaction
5%Hypocalcemia
5%Hypomagnesemia
This histogram enumerates side effects from a completed 2022 Phase 2 trial (NCT03018080) in the Arm A (Phased Pembrolizumab Regimen) ARM group. Side effects include: Fatigue with 71%, Peripheral sensory neuropathy with 43%, Headache with 38%, Alopecia with 38%, Nausea with 33%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

5 Treatment Groups

Cohort 1 LN-145 monotherapy
1 of 5
Cohort 2 LN-145 monotherapy
1 of 5
Cohort 5 Retreatment Cohort
1 of 5
Cohort 3 - Combination Arm (TIL + Pembrolizumab) - US Only
1 of 5
Cohort 4 - Non-enrolling Cohort
1 of 5

Experimental Treatment

189 Total Participants · 5 Treatment Groups

Primary Treatment: LN-145 · No Placebo Group · Phase 2

Cohort 1 LN-145 monotherapy
Biological
Experimental Group · 1 Intervention: LN-145 · Intervention Types: Biological
Cohort 2 LN-145 monotherapy
Biological
Experimental Group · 1 Intervention: LN-145 · Intervention Types: Biological
Cohort 5 Retreatment Cohort
Biological
Experimental Group · 1 Intervention: LN-145 · Intervention Types: Biological
Cohort 3 - Combination Arm (TIL + Pembrolizumab) - US Only
Biological
Experimental Group · 1 Intervention: LN-145 + pembrolizumab · Intervention Types: Biological
Cohort 4 - Non-enrolling Cohort
Biological
Experimental Group · 1 Intervention: LN-145 · Intervention Types: Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LN-145
2017
Completed Phase 2
~120

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 60 months

Who is running the clinical trial?

Iovance Biotherapeutics, Inc.Lead Sponsor
19 Previous Clinical Trials
1,546 Total Patients Enrolled
Iovance Medical MonitorStudy DirectorIovance Biotherapeutics, Inc.
1 Previous Clinical Trials

Eligibility Criteria

Age 18+ · Female Participants · 3 Total Inclusion Criteria

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References

Frequently Asked Questions

What medical conditions does LN-145 typically address?

"LN-145 is an effective treatment option for malignant neoplasms, microsatellite instability high, and unresectable melanoma." - Anonymous Online Contributor

Unverified Answer

What potential risks could be associated with administering LN-145 to patients?

"With prior data backing its safety, but limited evidence for efficacy, LN-145 was assigned a score of 2 out of 3." - Anonymous Online Contributor

Unverified Answer

Is this research effort currently enrolling volunteers?

"Affirmative. The clinicaltrials.gov website attests that this medical experiment, first posted on June 22nd 2017, is presently looking for participants. Approximately 189 people need to be recruited from 19 different sites." - Anonymous Online Contributor

Unverified Answer

Are there various sites in the city that are conducting this experiment?

"Eligible patients may be recruited to this clinical trial in three major sites, including University of Southern California Los Angeles (California), University of Chicago (Illinois) and University of California San Diego (Florida). Additionally, there are 19 other recruitment centres." - Anonymous Online Contributor

Unverified Answer

What is the aim of this investigation?

"This clinical trial's primary goal is to gauge the efficacy and adverse events of LN-145 over a 60 month period. Secondary objectives include measuring disease control rate, overall survival, and side effects in patients with recurrent, metastatic or persistent cervical carcinoma as per RECIST v1.1 guidelines." - Anonymous Online Contributor

Unverified Answer

What is the sample size of this research experiment?

"Iovance Biotherapeutics, Inc. has set a target of 189 participants for this trial; these individuals must meet the defined inclusion criteria in order to be eligible. This clinical study will take place at University of Southern California and University of Chicago, amongst other medical facilities." - Anonymous Online Contributor

Unverified Answer

Have any preceding investigations explored the use of LN-145?

"LN-145 was initially analyzed in 2010 at the City of Hope. Presently, there are 250 studies that have been completed as well as 961 active trials taking place largely within Los Angeles County." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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