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Autologous Tumor Infiltrating Lymphocytes MDA-TIL in Treating Patients With Recurrent or Refractory Ovarian Cancer, Colorectal Cancer, or Pancreatic Ductal Adenocarcinoma

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ClinicalTrials.gov Identifier: NCT03610490
Recruitment Status : Recruiting
First Posted : August 1, 2018
Last Update Posted : September 27, 2019
Sponsor:
Collaborators:
Bristol-Myers Squibb
Iovance Biotherapeutics
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date  ICMJE July 24, 2018
First Posted Date  ICMJE August 1, 2018
Last Update Posted Date September 27, 2019
Actual Study Start Date  ICMJE August 17, 2018
Estimated Primary Completion Date September 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
Objective response rate (ORR) [ Time Frame: Up to 5 years ]
Will be measured by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. ORR will use 80% confidence interval by the Wilson score method.
Original Primary Outcome Measures  ICMJE
 (submitted: July 31, 2018)
Objective response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria [ Time Frame: Up to 5 years ]
ORR will use 80% confidence interval by the Wilson score method.
Change History Complete list of historical versions of study NCT03610490 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
  • Complete response rate (CRR) [ Time Frame: Up to 5 years ]
    Will be measured by RECIST 1.1 criteria. CRR will adopt the 2-sided 95% criteria.
  • Disease control rate (DCR) [ Time Frame: Up to 5 years ]
    Will be measured by RECIST 1.1 criteria. DCR will adopt the 2-sided 95% criteria. DCR includes complete response, partial response, and stable disease.
  • Duration of response (DOR) [ Time Frame: Up to 5 years ]
    Will be measured by RECIST 1.1 criteria. DOR will adopt the 2-sided 95% criteria.
  • Progression-free survival (PFS) [ Time Frame: At 6 and 12 months ]
    Will be measured by RECIST 1.1 criteria. PFS will be summarized using Kaplan-Meier estimates.
  • Overall survival (OS) [ Time Frame: At 6 and 12 months ]
    OS will be summarized using Kaplan-Meier estimates.
  • Incidence of adverse events [ Time Frame: Up to 5 years ]
    Will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Safety endpoints will include overall assessment of adverse events (AEs) including grade 3 or greater non-hematological toxicities, serious adverse events and treatment-emergent AEs by grade and relationship to the study treatment.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2018)
  • Complete response rate (CRR) as measured by RECIST 1.1 criteria [ Time Frame: Up to 5 years ]
    CRR will adopt the 2-sided 95% criteria.
  • Disease control rate (DCR) as measured by RECIST 1.1 criteria [ Time Frame: Up to 5 years ]
    DCR will adopt the 2-sided 95% criteria. DCR includes complete response, partial response, and stable disease.
  • Duration of response (DOR) as measured by RECIST 1.1 criteria [ Time Frame: Up to 5 years ]
    DOR will adopt the 2-sided 95% criteria.
  • Progression-free survival (PFS) as measured by RECIST 1.1 criteria [ Time Frame: At 6 and 12 months ]
    PFS will be summarized using Kaplan-Meier estimates.
  • Overall survival (OS) [ Time Frame: At 6 and 12 months ]
    OS will be summarized using Kaplan-Meier estimates.
  • Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 [ Time Frame: Up to 5 years ]
    Safety endpoints will include overall assessment of adverse events (AEs) including grade 3 or greater non-hematological toxicities, serious adverse events and treatment-emergent AEs by grade and relationship to the study treatment.
Current Other Pre-specified Outcome Measures
 (submitted: May 9, 2019)
  • Duration of tumor infiltrating lymphocyte (TIL) persistence [ Time Frame: Up to 5 years ]
    Duration of TIL persistence is determined by T cell receptor (TCR) sequencing of infused T cells serially isolated following MDA-TIL infusion, or alternatively iRepertoire assessment of messenger ribonucleic acid for the TCRs. A paired t-test will be used to examine the molecular and immunological features of tumors before and after TIL therapy. Pearson correlation coefficient and linear regression, when appropriate, will be used to quantify the relationship between phenotypic attributes (CD8 %, CD27 and CD28 expression, etc.) and response to therapy.
  • Response [ Time Frame: Up to 5 years ]
    Will be determined by the immune-related response criteria. A paired t-test will be used to examine the molecular and immunological features of tumors before and after TIL therapy. Pearson correlation coefficient and linear regression, when appropriate, will be used to quantify the relationship between phenotypic attributes (CD8 %, CD27 and CD28 expression, etc.) and response to therapy.
  • Assessment of immunological phenotype of autologous tumor infiltrating lymphocytes MDA-TIL [ Time Frame: At the time of infusion ]
    A paired t-test will be used to examine the molecular and immunological features of tumors before and after TIL therapy. Pearson correlation coefficient and linear regression, when appropriate, will be used to quantify the relationship between phenotypic attributes (CD8 %, CD27 and CD28 expression, etc.) and response to therapy.
  • Tumor assessment [ Time Frame: Up to 5 years ]
    Will be determined by immunohistochemistry, TCR sequencing, and transcriptional analysis. A paired t-test will be used to examine the molecular and immunological features of tumors before and after TIL therapy. Pearson correlation coefficient and linear regression, when appropriate, will be used to quantify the relationship between phenotypic attributes (CD8 %, CD27 and CD28 expression, etc.) and response to therapy.
  • Health-related quality of life [ Time Frame: Up to 5 years ]
    Will be assessed by European Organization for Research and Treatment of Cancer core 30 quality of life questionnaire. A paired t-test will be used to examine the molecular and immunological features of tumors before and after TIL therapy. Pearson correlation coefficient and linear regression, when appropriate, will be used to quantify the relationship between phenotypic attributes (CD8 %, CD27 and CD28 expression, etc.) and response to therapy.
Original Other Pre-specified Outcome Measures
 (submitted: July 31, 2018)
  • Duration of tumor infiltrating lymphocyte (TIL) persistence [ Time Frame: Up to 5 years ]
    Duration of TIL persistence is determined by T cell receptor (TCR) sequencing of infused T cells serially isolated following MDA-TIL infusion, or alternatively iRepertoire assessment of messenger ribonucleic acid for the TCRs. A paired t-test will be used to examine the molecular and immunological features of tumors before and after TIL therapy. Pearson correlation coefficient and linear regression, when appropriate, will be used to quantify the relationship between phenotypic attributes (CD8 %, CD27 and CD28 expression, etc.) and response to therapy.
  • Response as determined by the immune-related response criteria [ Time Frame: Up to 5 years ]
    A paired t-test will be used to examine the molecular and immunological features of tumors before and after TIL therapy. Pearson correlation coefficient and linear regression, when appropriate, will be used to quantify the relationship between phenotypic attributes (CD8 %, CD27 and CD28 expression, etc.) and response to therapy.
  • Assessment of immunological phenotype of autologous tumor infiltrating lymphocytes MDA-TIL [ Time Frame: 6 weeks and 12 weeks after infusion ]
    A paired t-test will be used to examine the molecular and immunological features of tumors before and after TIL therapy. Pearson correlation coefficient and linear regression, when appropriate, will be used to quantify the relationship between phenotypic attributes (CD8 %, CD27 and CD28 expression, etc.) and response to therapy.
  • Tumor assessment as determined by immunohistochemistry, TCR sequencing, and transcriptional analysis [ Time Frame: Up to 5 years ]
    A paired t-test will be used to examine the molecular and immunological features of tumors before and after TIL therapy. Pearson correlation coefficient and linear regression, when appropriate, will be used to quantify the relationship between phenotypic attributes (CD8 %, CD27 and CD28 expression, etc.) and response to therapy.
  • Health-related quality of life as assessed by European Organization for Research and Treatment of Cancer core 30 quality of life questionnaire [ Time Frame: Up to 5 years ]
    A paired t-test will be used to examine the molecular and immunological features of tumors before and after TIL therapy. Pearson correlation coefficient and linear regression, when appropriate, will be used to quantify the relationship between phenotypic attributes (CD8 %, CD27 and CD28 expression, etc.) and response to therapy.
 
Descriptive Information
Brief Title  ICMJE Autologous Tumor Infiltrating Lymphocytes MDA-TIL in Treating Patients With Recurrent or Refractory Ovarian Cancer, Colorectal Cancer, or Pancreatic Ductal Adenocarcinoma
Official Title  ICMJE Clinical Study to Assess Efficacy and Safety of MDA-TIL (Autologous Expanded Tumor Infiltrating Lymphocytes) Across Multiple Tumor Types
Brief Summary This phase II trial studies how well autologous tumor infiltrating lymphocytes MDA-TIL works in treating patients with ovarian cancer, colorectal cancer, or pancreatic ductal adenocarcinoma that has come back (recurrent) or does not respond to treatment (refractory). Autologous tumor infiltrating lymphocytes MDA-TIL, made by collecting and growing specialized white blood cells (called T-cells) from a patient's tumor, may help to stimulate the immune system in different ways to stop tumor cells from growing.
Detailed Description

PRIMARY OBJECTIVE:

I. To evaluate efficacy using objective response rate (ORR) using the Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 in subjects with ovarian cancer, pancreatic ductal adenocarcinoma (PDAC), and colorectal cancers.

SECONDARY OBJECTIVES:

I. Determine the disease control rate (DCR) within and across cohorts. II. Determine the duration of response (DOR). III. Determine progression-free survival (PFS) and overall survival (OS). IV. Further characterize the safety profile of adoptive cell therapy (ACT) with tumor-infiltrating lymphocytes (TIL) across multiple tumor types.

EXPLORATORY OBJECTIVES:

I. Establish duration of TIL persistence. II. Compare the molecular and immunological features of tumors before and after TIL therapy.

III. Prospectively evaluate the existing immunotherapy response criteria (irRECIST) as the best response assessment tool for TIL therapy among a diverse group of solid tumors.

IV. Investigate TIL attributes (CD8 %, CD27 and CD28 expression) and correlation with response to therapy.

V. Assess tumor marker (CA19-9; CA-125) response in patients who produce this tumor marker.

VI. Assess Health-Related Quality of Life (HRQOL).

OUTLINE:

LYMPHODEPLETION REGIMEN: Patients receive cyclophosphamide intravenously (IV) over 2 hours on days -7 and -6, and fludarabine IV over 30 minutes on days -5 to -1 in the absence of disease progression or unacceptable toxicity.

T-CELL INFUSION: Patients receive autologous tumor infiltrating lymphocytes MDA-TIL IV over 45 minutes on day 0. Patients then receive IL-2 IV over 30 minutes on days 1-4 for up to 6 doses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at week 18, at 6, 9, 12, 18, and 24 months, and then every 3 months for up to 3 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • High Grade Ovarian Serous Adenocarcinoma
  • Metastatic Colorectal Adenocarcinoma
  • Oligometastasis
  • Ovarian Carcinosarcoma
  • Pancreatic Ductal Adenocarcinoma
  • Recurrent Colorectal Carcinoma
  • Recurrent Ovarian Carcinoma
  • Refractory Colorectal Carcinoma
  • Refractory Ovarian Carcinoma
  • Stage IV Colorectal Cancer AJCC v8
Intervention  ICMJE
  • Biological: Autologous Tumor Infiltrating Lymphocytes MDA-TIL
    Given IV
    Other Names:
    • MDA Autologous TILs
    • MDA Autologous Tumor Infiltrating Lymphocytes
    • MDA-TILs
  • Drug: Cyclophosphamide
    Given IV
    Other Names:
    • (-)-Cyclophosphamide
    • 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
    • Carloxan
    • Ciclofosfamida
    • Ciclofosfamide
    • Cicloxal
    • Clafen
    • Claphene
    • CP monohydrate
    • CTX
    • CYCLO-cell
    • Cycloblastin
    • Cycloblastine
    • Cyclophospham
    • Cyclophosphamid monohydrate
    • Cyclophosphamide Monohydrate
    • Cyclophosphamidum
    • Cyclophosphan
    • Cyclophosphane
    • Cyclophosphanum
    • Cyclostin
    • Cyclostine
    • Cytophosphan
    • Cytophosphane
    • Cytoxan
    • Fosfaseron
    • Genoxal
    • Genuxal
    • Ledoxina
    • Mitoxan
    • Neosar
    • Revimmune
    • Syklofosfamid
    • WR- 138719
  • Drug: Fludarabine
    Given IV
    Other Name: Fluradosa
  • Drug: Fludarabine Phosphate
    Given IV
    Other Names:
    • 2-F-ara-AMP
    • 9H-Purin-6-amine, 2-fluoro-9-(5-O-phosphono-.beta.-D-arabinofuranosyl)-
    • Beneflur
    • Fludara
    • SH T 586
  • Biological: Interleukin-2
    Given IV
    Other Names:
    • Epidermal Thymocyte Activating Factor
    • ETAF
    • IL-2
    • IL2
    • IL2 Protein
    • Interleukin 2
    • Interleukin 2 Precursor
    • Interleukin II
    • Lymphocyte Mitogenic Factor
    • Mitogenic Factor
    • Ro-236019
    • T Cell Growth Factor
    • T-Cell Growth Factor
    • TCGF
    • Thymocyte Stimulating Factor
    • TSF
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Name: Quality of Life Assessment
Study Arms  ICMJE Experimental: Treatment (autologous tumor infiltrating lymphocytes MDA-TIL)

LYMPHODEPLETION REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days -7 and -6, and fludarabine IV over 30 minutes on days -5 to -1 in the absence of disease progression or unacceptable toxicity.

T-CELL INFUSION: Patients receive autologous tumor infiltrating lymphocytes MDA-TIL IV over 45 minutes on day 0. Patients then receive IL-2 IV over 30 minutes on days 1-4 for up to 6 doses in the absence of disease progression or unacceptable toxicity.

Interventions:
  • Biological: Autologous Tumor Infiltrating Lymphocytes MDA-TIL
  • Drug: Cyclophosphamide
  • Drug: Fludarabine
  • Drug: Fludarabine Phosphate
  • Biological: Interleukin-2
  • Other: Quality-of-Life Assessment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 31, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2021
Estimated Primary Completion Date September 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects must be willing and able to provide informed consent. For patients < 18 years of age, their parents or legal guardians must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines
  • Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0 or 1 at enrollment and within 7 days of initiating lymphodepleting chemotherapy
  • Subjects must have an area of tumor amenable to excisional biopsy (core biopsies may be allowed) for the generation of TIL separate from, and in addition to, a target lesion to be used for response assessment
  • Any prior therapy directed at the malignant tumor, including radiation therapy, chemotherapy, and biologic/targeted agents must be discontinued at least 28 days prior to tumor resection for preparing TIL therapy
  • Absolute neutrophil count (ANC) >= 1000/mm^3 (within 7 days of enrollment and with 24 hours of starting lymphodepleting chemotherapy)
  • Hemoglobin >= 9.0 g/dL (transfusion allowed) (within 7 days of enrollment and with 24 hours of starting lymphodepleting chemotherapy)
  • Platelet count >= 100,000/mm^3 (within 7 days of enrollment and with 24 hours of starting lymphodepleting chemotherapy)
  • Alanine aminotransferase (ALT)/serum glutamate pyruvate transaminase (SGPT) and aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) < 2.5 x the upper limit of normal (ULN) (patients with liver metastases may have liver function test [LFT] =< 5.0 x ULN) (within 7 days of enrollment and with 24 hours of starting lymphodepleting chemotherapy)
  • Calculated creatinine clearance (Cockcroft-Gault) >= 50.0 mL/min (within 7 days of enrollment and with 24 hours of starting lymphodepleting chemotherapy)
  • Total bilirubin =< 1.5 x ULN (within 7 days of enrollment and with 24 hours of starting lymphodepleting chemotherapy)
  • Prothrombin time (PT) & activated partial thromboplastin time (aPTT) =< 1.5 x ULN (correction with vitamin K allowed) unless subject is receiving anticoagulant therapy (which should be managed according to institutional norms prior to and after excisional biopsy) (within 7 days of enrollment and with 24 hours of starting lymphodepleting chemotherapy)
  • Negative serum pregnancy test (female subjects of childbearing potential) (within 7 days of enrollment and with 24 hours of starting lymphodepleting chemotherapy)
  • Subjects must not have a confirmed human immunodeficiency virus (HIV) infection
  • Subjects must have a 12-lead electrocardiogram (EKG) showing no active ischemia and Fridericia's corrected QT interval (QTcF) less than 480 ms
  • Subjects must also have a negative dobutamine stress echocardiogram before beginning treatment
  • Subjects of childbearing potential must be willing to practice an approved highly effective method of birth control starting at the time of informed consent and for 1 year after the completion of the lymphodepletion regimen. Approved methods of birth control are as follows: hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation or hysterectomy; subject/partner status post vasectomy; implantable or injectable contraceptives; and condoms plus spermicide
  • Able to adhere to the study visit schedule and other protocol requirements
  • Pulmonary function tests (spirometry) demonstrating forced expiratory value (FEV) 1 greater than 65% predicted or forced vital capacity (FVC) greater than 65% of predicted
  • Ovarian cancer cohort only: Subjects must have high grade non-mucinous histology (carcinosarcomas are allowed)
  • Ovarian cancer cohort only: Subjects must have failed at least two prior lines of chemotherapy (i.e. frontline adjuvant chemotherapy plus one additional line for recurrent/progressive disease)
  • Colorectal cohort only: Subjects with colorectal adenocarcinoma must have metastatic disease that is considered incurable with currently available therapies and have derived maximal benefit from or have become refractory to frontline conventional therapy (e.g. leucovorin calcium [calcium folinate], 5-fluorouracil and oxaliplatin [FOLFOX], leucovorin calcium, 5-fluorouracil, and irinotecan [FOLFIRI]).
  • Colorectal cohort only: Subjects should have low disease burden such that in the treating physician's opinion the patient would not require additional intervening treatment for 7-8 weeks (required for TIL harvest and manufacturing)
  • Pancreatic adenocarcinoma cohort only: Subjects must have histologically or cytologically documented diagnosis of PDAC with oligo-metastatic disease
  • Pancreatic adenocarcinoma cohort only: Subjects must have progressed on, or received maximal benefit from, front-line therapy
  • Pancreatic adenocarcinoma cohort only: Patients may have received unlimited lines of prior standard of care therapy
  • Pancreatic adenocarcinoma cohort only: Patients with ascites or carcinomatosis are not eligible for the study
  • Pancreatic adenocarcinoma cohort only: Patients will need an albumin of >= 3.0 mg/dL within 7 days of enrollment

Exclusion Criteria:

  • Active systemic infections requiring intravenous antibiotics, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system. Principal investigator (PI) or his/her designee shall make the final determination regarding appropriateness of enrollment
  • Patients with active viral hepatitis
  • Patients who have a left ventricular ejection fraction (LVEF) < 45% at screening
  • Patients with a history of prior adoptive cell therapies
  • Persistent prior therapy-related toxicities greater than grade 2 according to Common Toxicity Criteria for Adverse Events (CTCAE) v. 4.03, except for peripheral neuropathy, alopecia, or vitiligo prior to enrollment
  • Primary immunodeficiency
  • History of organ or hematopoietic stem cell transplant
  • Chronic steroid therapy, however prednisone or its equivalent is allowed at < 10 mg/day
  • Patients who are pregnant or nursing
  • Presence of a significant psychiatric disease, which in the opinion of the principal investigator or his/her designee, would prevent adequate informed consent
  • History of clinically significant autoimmune disease including active, known, or suspected autoimmune disease. Subjects with resolved side effects from prior checkpoint inhibitor therapy, vitiligo, psoriasis, type 1 diabetes or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded. Subjects with hypothyroidism stable on hormone replacement or Sjogren's syndrome will not be excluded
  • History of clinically significant chronic obstructive pulmonary disease (COPD), asthma, or other chronic lung disease
  • History of a second malignancy (diagnosed in the last 5 years). Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy
  • History of known active central nervous system metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to initiation of lymphodepletion
  • Has received a live vaccine within 30 days prior to the initiation of lymphodepletion
  • Patients who have a contraindication to or history of hypersensitivity reaction to any components or excipients of the TIL therapy or the other study drugs: NMA-LD (cyclophosphamide, mesna, and fludarabine); IL-2; any component of the TIL infusion product formulation including human serum albumin (HSA), IL-2, and dextran-40
  • Any other condition that in the investigator's judgement would significantly increase the risks of participation
  • Patient has any complication or delayed healing from excisional procedure that in the investigator's opinion would increase the risks of lymphodepletion, adoptive TIL therapy and adjuvant IL-2
  • Patients has a decline in performance status to ECOG > 1 (at the visit prior to admission for lymphodepletion)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Amir A. Jazaeri 713-563-4598 aajazaeri@mdanderson.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03610490
Other Study ID Numbers  ICMJE 2017-0671
NCI-2018-01509 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2017-0671 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE
  • Bristol-Myers Squibb
  • Iovance Biotherapeutics
  • National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Amir A Jazaeri M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP