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Iovance Biotherapeutics Inc (IOVA)
NASDAQ:IOVA
Iov-3001
Metastatic Melanoma, Unresectable Melanoma, Ocular Melanoma
Phase I/II
Recruiting
A Study to Investigate the Safety and Efficacy of IOV-3001 in Adults With Advanced Melanoma Who Will Receive Lifileucel
Apr 08, 2025
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Ln-145/Ln-144
Melanoma, Ewing Sarcoma, Soft Tissue Sarcoma, Rhabdomyosarcoma, Primary Central Nervous System Carcinoma
Phase I
Recruiting
Study of Autologous Tumor-Infiltrating Lymphocytes in Pediatric, Adolescent, and Young Adult Participants
Jul 17, 2024
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Lifileucel
Endometrial Cancer
Phase II
Recruiting
A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Endometrial Cancer.
Jun 25, 2024
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Lifileucel Plus Pembrolizumab, Pembrolizumab With Optional Crossover Period
Melanoma, Metastatic Melanoma, Unresectable Melanoma
Phase III
Recruiting
Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma.
Feb 06, 2023
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Iov-4001
Metastatic Melanoma, Stage Iv Non-Small Cell Lung Cancer, Stage Iii Non-Small Cell Lung Cancer, Unresectable Melanoma
Phase I/II
Recruiting
A Study to Investigate the Efficacy and Safety of an Infusion of IOV-4001 in Adult Participants With Unresectable or Metastatic Melanoma or Stage III or IV Non-small-cell Lung Cancer
Apr 29, 2022
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Ln-145
Metastatic Non Small Cell Lung Cancer
Phase II
Recruiting
Autologous LN-145 in Patients With Metastatic Non-Small-Cell Lung Cancer
Oct 21, 2020
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Il-2, Iov-2001, Low Dose Il-2, High Dose Il-2
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Phase I/II
Completed
Study of Autologous Peripheral Blood Lymphocytes in the Treatment of Patients With CLL or SLL
Nov 04, 2019
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Pembrolizumab, Nab-paclitaxel, Nivolumab, Ipilimumab, Pemetrexed, Paclitaxel, Carboplatin, Cisplatin, Lifileucel, Ln-145, Ln-145-S1, Nivolumab-Relatlimab
Non-small Cell Lung Cancer, Metastatic Melanoma, Squamous Cell Carcinoma Of The Head And Neck
Phase II
Recruiting
Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors
Aug 22, 2018
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Ln-145, Ln-145 + Pembrolizumab
Cervical Carcinoma
Phase II
Terminated
Study of LN-145, Autologous Tumor Infiltrating Lymphocytes in the Treatment of Patients With Cervical Carcinoma
Mar 27, 2017
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Lifileucel
Metastatic Melanoma
Phase II
Completed
Study of Lifileucel (LN-144), Autologous Tumor Infiltrating Lymphocytes, in the Treatment of Patients With Metastatic Melanoma
Feb 03, 2015
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Iovance Biotherapeutics Inc (IOVA) have in its pipeline
IOVA is currently developing the following drugs: Iov-3001, Ln-145/Ln-144, Lifileucel. These drug candidates are in various stages of clinical development as the company works toward FDA approval.