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Trial record 23 of 101 for:    "Sarcoma, Synovial"

Safety and Efficacy of IMCnyeso in Advanced NY-ESO-1 and/or LAGE-1A Positive Cancers

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ClinicalTrials.gov Identifier: NCT03515551
Recruitment Status : Recruiting
First Posted : May 3, 2018
Last Update Posted : June 26, 2019
Sponsor:
Information provided by (Responsible Party):
Immunocore Ltd

Tracking Information
First Submitted Date  ICMJE April 5, 2018
First Posted Date  ICMJE May 3, 2018
Last Update Posted Date June 26, 2019
Actual Study Start Date  ICMJE June 15, 2018
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2018)
  • Recommended phase 2 dose (RP2D) [ Time Frame: From day 1 to day 28 of treatment ]
  • Number of patients with treatment emergent AEs [ Time Frame: Safety will be assessed from informed consent through 90 days after end of treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03515551 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2018)
  • Objective response rate (ORR) defined as the proportion of patients achieving an objective response (RECIST v1.1 and modified irRECIST) (Arm 2 only) [ Time Frame: Up to 2 years ]
  • Disease control rate (DCR) defined as the proportion of patients with either an objective response or stable disease (RECIST v1.1 and modified irRECIST). (Part 2 only) [ Time Frame: Up to 2 years ]
  • Pharmacokinetics [ Time Frame: 2 weeks (AUC will be assessed weekly for 2 weeks) ]
    Area under the plasma concentration-time curve (AUC)
  • Pharmacokinetics [ Time Frame: Up to 2 years ]
    The maximum observed plasma drug concentration after single dose administration (Cmax)
  • Pharmacokinetics [ Time Frame: Up to 2 years ]
    The time to reach maximum plasma concentration (Tmax)
  • Pharmacokinetics [ Time Frame: 2 weeks (t1/2 will be assessed after the first two doses of IMCnyeso, an average of 2 weeks) ]
    The elimination half-life (t1/2)
  • Pharmacokinetics [ Time Frame: up to 2 years ]
    The incidence of anti-IMCnyeso antibody formation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of IMCnyeso in Advanced NY-ESO-1 and/or LAGE-1A Positive Cancers
Official Title  ICMJE A Phase I/II Study of IMCnyeso, HLA- A*0201-Restricted, NY-ESO-1- and LAGE-1A-specific Soluble T Cell Receptor and Anti-CD3 Bispecific Molecule, in HLA-A*0201 Positive Patients With Advanced NY-ESO-1 and/or LAGE - 1A Positive Cancer
Brief Summary IMCnyeso is a new biological therapy designed for the treatment of cancers which express NY-ESO-1 and/or LAGE-1A. This is a first-in-human trial designed to evaluate the safety and efficacy of IMCnyeso in adult patients who have the appropriate HLA-A2 tissue marker and whose cancer is positive for NY-ESO-1 and/or LAGE-A1.
Detailed Description This is a multi-center, open label, dose finding Phase 1/2 study of single agent IMCnyeso administered in patients with NY-ESO-1 and/or LAGE-A1 positive tumors. The study consists of 2 Arms. In the first Arm (the dose escalation phase), IMCnyeso will be evaluated in 4 diseases (advanced non-small cell cancer (NSCLC), melanoma, urothelial carcinoma, and synovial sarcoma). The primary objective of this Arm is to determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) of IMCnyeso. The second Arm is an expansion phase in which the dose determined in Arm 1 will be tested in 3 diseases (advanced NSCLC, urothelial carcinoma and synovial sarcoma) to further evaluate the safety and assess the anti-tumor activity of IMCnyeso
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Melanoma
  • Advanced NSCLC
  • Urothelial Carcinoma
  • Synovial Sarcoma
Intervention  ICMJE
  • Drug: IMCnyeso
    Weekly IV infusions of IMCnyeso. The dose administered in each cohort will be determined following a review of the safety, PK and efficacy data and the dose will be guided by the Bayesian Logistic Regression Model, in order to determine the RP2D.
  • Drug: IMCnyeso
    Weekly IV infusions of IMCnyeso at the MTD or RP2D determined in Arm 1
Study Arms  ICMJE
  • Experimental: IMCnyeso dose Escalation Phase (Arm 1)
    Phase (Arm 1) n=up to 33 Melanoma, NSCLC, urothelial carcinoma and synovial sarcoma patients to establish the MTD/RP2D
    Intervention: Drug: IMCnyeso
  • Experimental: IMCnyeso expansion phase (Arm 2)
    Patients will be enrolled into 1 of 3 cohorts depending on disease type (NSCLC, urothelial carcinoma or synovial sarcoma) n=30 and treated at the RP2D of IMCnyso to determine the efficacy in these indications
    Intervention: Drug: IMCnyeso
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: May 2, 2018)
63
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female patients age ≥ 18 years of age at the time of informed consent
  2. HLA-A*0201 positive, confirmed by central laboratory
  3. NY-ESO-1 and/or LAGE-1A positive tumor confirmed by the central laboratory
  4. Arm 1: Patients must be refractory to or intolerant to all existing therapies known to provide clinical benefit for their condition.
  5. Arm 2: Subjects will have received the following previous therapies:

    1. NSCLC — PD-1/PD-L1 inhibitor
    2. Patients with NSCLC and an EGFR or ALK genomic tumor aberration must have disease progression after treatment with Health Authority-approved agents for these aberrations
    3. Urothelial cancer — PD-1/PD-L1 inhibitor
    4. Synovial sarcoma — at least one prior chemotherapy regimen
  6. Arm 1 only: Histologically confirmed diagnosis of advanced NSCLC, melanoma, urothelial carcinoma, or synovial sarcoma
  7. Arm 2 only: Histologically confirmed diagnosis of advanced NSCLC, urothelial carcinoma, or synovial sarcoma
  8. Arm 2 only: Disease amenable to biopsy
  9. Arm 2 only: Measurable disease to RECIST v.1.1 criteria

Exclusion Criteria:

Impaired baseline organ function as evaluated by out-of-range laboratory values 2. History of severe hypersensitivity reactions (eg, anaphylaxis) to other biologic drugs or monoclonal antibodies 3. Clinically significant cardiac disease or impaired cardiac function 4. Presence of symptomatic or untreated central nervous system (CNS) metastases 5. Active infection requiring systemic antibiotic therapy 6. Known history of human immunodeficiency virus infection (HIV) 7. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection 8. Malignant disease, other than that being treated in this study 9. Patients receiving systemic steroid therapy or any other systemic immunosuppressive medication. Local steroid therapies are acceptable 10. Systemic anti-cancer therapy within 2 weeks of the first dose of study drug.

11. Major surgery within 2 weeks of the first dose of study drug 12. Radiotherapy within 2 weeks of the first dose of study drug, with the exception of palliative radiotherapy to a limited field 13. Use of hematopoietic colony-stimulating growth factors (eg, G-CSF, GM-CSF, M-CSF) ≤ 2 weeks prior to start of study drug 14. Pregnant, likely to become pregnant, or lactating women

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Shannon Marshall 484-534-5261 clinicaltrials@immunocore.com
Contact: Meggan Tammaro 484-534-5261 Clinicaltrials@immunocore.com
Listed Location Countries  ICMJE United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03515551
Other Study ID Numbers  ICMJE IMCnyeso-101
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Immunocore Ltd
Study Sponsor  ICMJE Immunocore Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Immunocore Ltd
Verification Date June 2019

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