Combination of a Personalized Therapeutic Anti-tumor Vaccine With Pembrolizumab in Non-Small Cell Lung Cancer

ID: NCT03166254
Status: Not yet recruiting
Phase: Phase 1
Start Date: March 31, 2018
First Submitted: May 23, 2017
Last Updated: February 13, 2018
Results: N/A
Sponsors & Collaborators: Washington University School of Medicine
Location: United States
Conditions: Non Small Cell Lung Cancer, NSCLC
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Study Description

Brief Summary

Metastatic non-small cell lung cancer (NSCLC) is incurable with current therapies, but due to mutations induced by cigarette smoke, typically expresses a large number of altered proteins that can be recognized as foreign by the immune system. This antigenicity is thought to explain the efficacy of pembrolizumab as either a first or second line treatment in this disease. For patients who receive chemotherapy as a first line therapy, there is sound rationale for combination treatment with immunotherapy and a therapeutic antitumor vaccine as a maintenance strategy. Regardless of PD-L1 expression in the tumor, monoclonal antibodies that block PD-1/PD-L1 interactions are effective second line therapies after chemotherapy. In addition, by targeting the immune system against tumor specific antigens using a peptide vaccine, the efficacy of pembrolizumab alone is expected to be enhanced, with an improved response rate and prolonged overall survival with no additional toxicity.

This pilot study will provide a preliminary test of the feasibility of generating a personalized, tumor neoantigen-specific therapeutic vaccine and the safety of combining it with checkpoint blockade immunotherapy.

Detailed Description

Condition or disease Intervention/treatment Phase

Non Small Cell Lung Cancer

NSCLC

Drug: Pembrolizumab
Other Names
Keytruda
Biological: Personalized synthetic long peptide vaccine
Other Names
Procedure: Biopsy
Other Names
Drug: Poly ICLC
Other Names
Hiltonol
Procedure: Leukapheresis
Other Names
Procedure: Peripheral blood draw
Other Names
Phase 1

Tracking Information

First Submitted DateMay 23, 2017
Last Update Posted DateFebruary 13, 2018
Anticipated Start DateMarch 31, 2018
Anticipated Completion DateMay 31, 2027
Anticipated Primary Completion DateJuly 31, 2022
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Safety and feasibility of the combination of a personalized vaccine and pembrolizumab as measured by number of participants who experience a serious adverse event [Time Frame: 30 days following the completion of treatment (estimated to be 2 years and 16 weeks)]

    -The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Overall response rate as measured by RECIST 1.1 [Time Frame: Completion of treatment (estimated to be 2.25 years)]

    -The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria.

  • Progression-free survival (PFS) as measured by RECIST 1.1 [Time Frame: Up to 5 years after completion of treatment (estimated to be 7.25 years)]

    PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progressive disease: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.

  • Overall survival (OS) [Time Frame: Up to 5 years after completion of treatment (estimated to be 7.25 years)]

  • Number of predicted strong tumor associated mutant antigens and response [Time Frame: Completion of treatment (estimated to be 2.25 years)]

    -The association between response and genetic features in the pathway will also be assessed using contingency tables. Although data analysis will be primarily descriptive, permutation test will be used to rank the strength of association. Specifically, we first compute the observed test statistics for the differences between responders and non-responders. Then the null distribution of the test statistics will be generated by simulating 10,000 datasets where the status of response was randomly shuffled. The permutation p-values equal the proportion of simulations from the null distribution that exceed the observed test statistics.

  • Overall response rate as measured by immune-response related criteria (irRC) [Time Frame: Completion of treatment (estimated to be 2.25 years)]

    -The overall response according to the irRC is derived from time point response assessments (Based on tumor burden) as follows: irCR: complete disappearance of all lesions (whether measurable or not, and no new lesions); confirmation by a repeat, consecutive assessment no less than 4 weeks from the date first documented irPR: decrease in tumor burden ≥ 50% relative to baseline; confirmed by a consecutive assessment at least 4 weeks after first documentation irSD: not meeting criteria for irCR or irPR, in absence of irPD; does not require confirmation irPD: increase in tumor burden ≥ 25% relative to nadir (minimum recorded tumor burden); confirmation by a repeat, consecutive assessment no less than 4 weeks from the date first documented

  • Progression-free survival as measured by immune-response related criteria (irRC) [Time Frame: Up to 5 years after completion of treatment (estimated to be 7.25 years)]

    -PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleCombination of a Personalized Therapeutic Anti-tumor Vaccine With Pembrolizumab in Non-Small Cell Lung Cancer
Official TitlePilot Feasibility Study of the Combination of a Personalized Therapeutic Anti-tumor Vaccine With Pembrolizumab in Non-Small Cell Lung Cancer
Brief Summary

Metastatic non-small cell lung cancer (NSCLC) is incurable with current therapies, but due to mutations induced by cigarette smoke, typically expresses a large number of altered proteins that can be recognized as foreign by the immune system. This antigenicity is thought to explain the efficacy of pembrolizumab as either a first or second line treatment in this disease. For patients who receive chemotherapy as a first line therapy, there is sound rationale for combination treatment with immunotherapy and a therapeutic antitumor vaccine as a maintenance strategy. Regardless of PD-L1 expression in the tumor, monoclonal antibodies that block PD-1/PD-L1 interactions are effective second line therapies after chemotherapy. In addition, by targeting the immune system against tumor specific antigens using a peptide vaccine, the efficacy of pembrolizumab alone is expected to be enhanced, with an improved response rate and prolonged overall survival with no additional toxicity.

This pilot study will provide a preliminary test of the feasibility of generating a personalized, tumor neoantigen-specific therapeutic vaccine and the safety of combining it with checkpoint blockade immunotherapy.

Detailed Description

Study TypeInterventional
Study PhasePhase 1
Estimated Enrollment
20
Allocation
Not Available
Interventional Model
Single Group Assignment
Masking
None (Open Label)
Primary Purpose
Treatment
Conditions
Non Small Cell Lung Cancer
NSCLC
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: Pembrolizumab

Pembrolizumab will be given intravenously over the course of 30 minutes (-5 min/+10 min) at 200 mg every 21 days.

Other Names
Keytruda
Biological: Personalized synthetic long peptide vaccine

Each vaccination consists of up to 4 separate injections, with each syringe containing peptides from one of the up to four peptide pools combined with adjuvant (poly-ICLC).

Other Names
Procedure: Biopsy

Surgical or core needle biopsy of an accessible site

Other Names
Drug: Poly ICLC

-This is the adjuvant for the vaccine

Other Names
Hiltonol
Procedure: Leukapheresis

-At baseline and beginning of Cycle 6

Other Names
Procedure: Peripheral blood draw

-Baseline, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 8 Day 1, Cycle 10 Day 1, Time of response (if applicable), and time of progression (if applicable)

Other Names
Study Groups/Cohorts
Personalized Vaccine + Pembrolizumab
Surgical or core needle biopsy of an accessible site for sequence analysis to generate the personalized vaccine 6 weeks following enrollment (approximately 9 weeks following the last dose of systemic chemotherapy), a repeat CT scan will be done to document disease stability. Should disease progression be evident, patients will begin pembrolizumab until the personalized vaccine is available All patients will begin treatment with pembrolizumab on a 21-day cycle for up to a maximum of 2 years of therapy 12 weeks after enrollment Up to 2 doses of pembrolizumab can be given prior to vaccine preparation if there is a delay in vaccine formulation. Up to 20 personalized vaccine peptides will be administered Vaccine administration will occur on Days 1, 4, 8, and 15 during Cycle 1 and on Day 1 of Cycles 2, 5, and 8 Patients in clinically stable condition who are considered by the investigator to be deriving clinical benefit may continue therapy after disease progression

Study Arms
Experimental Personalized Vaccine + Pembrolizumab
Surgical or core needle biopsy of an accessible site for sequence analysis to generate the personalized vaccine 6 weeks following enrollment (approximately 9 weeks following the last dose of systemic chemotherapy), a repeat CT scan will be done to document disease stability. Should disease progression be evident, patients will begin pembrolizumab until the personalized vaccine is available All patients will begin treatment with pembrolizumab on a 21-day cycle for up to a maximum of 2 years of therapy 12 weeks after enrollment Up to 2 doses of pembrolizumab can be given prior to vaccine preparation if there is a delay in vaccine formulation. Up to 20 personalized vaccine peptides will be administered Vaccine administration will occur on Days 1, 4, 8, and 15 during Cycle 1 and on Day 1 of Cycles 2, 5, and 8 Patients in clinically stable condition who are considered by the investigator to be deriving clinical benefit may continue therapy after disease progression
Drug : Pembrolizumab
Pembrolizumab will be given intravenously over the course of 30 minutes (-5 min/+10 min) at 200 mg every 21 days.

Experimental Personalized Vaccine + Pembrolizumab
Surgical or core needle biopsy of an accessible site for sequence analysis to generate the personalized vaccine 6 weeks following enrollment (approximately 9 weeks following the last dose of systemic chemotherapy), a repeat CT scan will be done to document disease stability. Should disease progression be evident, patients will begin pembrolizumab until the personalized vaccine is available All patients will begin treatment with pembrolizumab on a 21-day cycle for up to a maximum of 2 years of therapy 12 weeks after enrollment Up to 2 doses of pembrolizumab can be given prior to vaccine preparation if there is a delay in vaccine formulation. Up to 20 personalized vaccine peptides will be administered Vaccine administration will occur on Days 1, 4, 8, and 15 during Cycle 1 and on Day 1 of Cycles 2, 5, and 8 Patients in clinically stable condition who are considered by the investigator to be deriving clinical benefit may continue therapy after disease progression
Biological : Personalized synthetic long peptide vaccine
Each vaccination consists of up to 4 separate injections, with each syringe containing peptides from one of the up to four peptide pools combined with adjuvant (poly-ICLC).

Experimental Personalized Vaccine + Pembrolizumab
Surgical or core needle biopsy of an accessible site for sequence analysis to generate the personalized vaccine 6 weeks following enrollment (approximately 9 weeks following the last dose of systemic chemotherapy), a repeat CT scan will be done to document disease stability. Should disease progression be evident, patients will begin pembrolizumab until the personalized vaccine is available All patients will begin treatment with pembrolizumab on a 21-day cycle for up to a maximum of 2 years of therapy 12 weeks after enrollment Up to 2 doses of pembrolizumab can be given prior to vaccine preparation if there is a delay in vaccine formulation. Up to 20 personalized vaccine peptides will be administered Vaccine administration will occur on Days 1, 4, 8, and 15 during Cycle 1 and on Day 1 of Cycles 2, 5, and 8 Patients in clinically stable condition who are considered by the investigator to be deriving clinical benefit may continue therapy after disease progression
Procedure : Biopsy
Surgical or core needle biopsy of an accessible site

Experimental Personalized Vaccine + Pembrolizumab
Surgical or core needle biopsy of an accessible site for sequence analysis to generate the personalized vaccine 6 weeks following enrollment (approximately 9 weeks following the last dose of systemic chemotherapy), a repeat CT scan will be done to document disease stability. Should disease progression be evident, patients will begin pembrolizumab until the personalized vaccine is available All patients will begin treatment with pembrolizumab on a 21-day cycle for up to a maximum of 2 years of therapy 12 weeks after enrollment Up to 2 doses of pembrolizumab can be given prior to vaccine preparation if there is a delay in vaccine formulation. Up to 20 personalized vaccine peptides will be administered Vaccine administration will occur on Days 1, 4, 8, and 15 during Cycle 1 and on Day 1 of Cycles 2, 5, and 8 Patients in clinically stable condition who are considered by the investigator to be deriving clinical benefit may continue therapy after disease progression
Drug : Poly ICLC
-This is the adjuvant for the vaccine

Experimental Personalized Vaccine + Pembrolizumab
Surgical or core needle biopsy of an accessible site for sequence analysis to generate the personalized vaccine 6 weeks following enrollment (approximately 9 weeks following the last dose of systemic chemotherapy), a repeat CT scan will be done to document disease stability. Should disease progression be evident, patients will begin pembrolizumab until the personalized vaccine is available All patients will begin treatment with pembrolizumab on a 21-day cycle for up to a maximum of 2 years of therapy 12 weeks after enrollment Up to 2 doses of pembrolizumab can be given prior to vaccine preparation if there is a delay in vaccine formulation. Up to 20 personalized vaccine peptides will be administered Vaccine administration will occur on Days 1, 4, 8, and 15 during Cycle 1 and on Day 1 of Cycles 2, 5, and 8 Patients in clinically stable condition who are considered by the investigator to be deriving clinical benefit may continue therapy after disease progression
Procedure : Leukapheresis
-At baseline and beginning of Cycle 6

Experimental Personalized Vaccine + Pembrolizumab
Surgical or core needle biopsy of an accessible site for sequence analysis to generate the personalized vaccine 6 weeks following enrollment (approximately 9 weeks following the last dose of systemic chemotherapy), a repeat CT scan will be done to document disease stability. Should disease progression be evident, patients will begin pembrolizumab until the personalized vaccine is available All patients will begin treatment with pembrolizumab on a 21-day cycle for up to a maximum of 2 years of therapy 12 weeks after enrollment Up to 2 doses of pembrolizumab can be given prior to vaccine preparation if there is a delay in vaccine formulation. Up to 20 personalized vaccine peptides will be administered Vaccine administration will occur on Days 1, 4, 8, and 15 during Cycle 1 and on Day 1 of Cycles 2, 5, and 8 Patients in clinically stable condition who are considered by the investigator to be deriving clinical benefit may continue therapy after disease progression
Procedure : Peripheral blood draw
-Baseline, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 8 Day 1, Cycle 10 Day 1, Time of response (if applicable), and time of progression (if applicable)

Arm Intervention/Treatment
Experimental Personalized Vaccine + Pembrolizumab
Surgical or core needle biopsy of an accessible site for sequence analysis to generate the personalized vaccine 6 weeks following enrollment (approximately 9 weeks following the last dose of systemic chemotherapy), a repeat CT scan will be done to document disease stability. Should disease progression be evident, patients will begin pembrolizumab until the personalized vaccine is available All patients will begin treatment with pembrolizumab on a 21-day cycle for up to a maximum of 2 years of therapy 12 weeks after enrollment Up to 2 doses of pembrolizumab can be given prior to vaccine preparation if there is a delay in vaccine formulation. Up to 20 personalized vaccine peptides will be administered Vaccine administration will occur on Days 1, 4, 8, and 15 during Cycle 1 and on Day 1 of Cycles 2, 5, and 8 Patients in clinically stable condition who are considered by the investigator to be deriving clinical benefit may continue therapy after disease progression
Drug : Pembrolizumab
Experimental Personalized Vaccine + Pembrolizumab
Surgical or core needle biopsy of an accessible site for sequence analysis to generate the personalized vaccine 6 weeks following enrollment (approximately 9 weeks following the last dose of systemic chemotherapy), a repeat CT scan will be done to document disease stability. Should disease progression be evident, patients will begin pembrolizumab until the personalized vaccine is available All patients will begin treatment with pembrolizumab on a 21-day cycle for up to a maximum of 2 years of therapy 12 weeks after enrollment Up to 2 doses of pembrolizumab can be given prior to vaccine preparation if there is a delay in vaccine formulation. Up to 20 personalized vaccine peptides will be administered Vaccine administration will occur on Days 1, 4, 8, and 15 during Cycle 1 and on Day 1 of Cycles 2, 5, and 8 Patients in clinically stable condition who are considered by the investigator to be deriving clinical benefit may continue therapy after disease progression
Biological : Personalized synthetic long peptide vaccine
Experimental Personalized Vaccine + Pembrolizumab
Surgical or core needle biopsy of an accessible site for sequence analysis to generate the personalized vaccine 6 weeks following enrollment (approximately 9 weeks following the last dose of systemic chemotherapy), a repeat CT scan will be done to document disease stability. Should disease progression be evident, patients will begin pembrolizumab until the personalized vaccine is available All patients will begin treatment with pembrolizumab on a 21-day cycle for up to a maximum of 2 years of therapy 12 weeks after enrollment Up to 2 doses of pembrolizumab can be given prior to vaccine preparation if there is a delay in vaccine formulation. Up to 20 personalized vaccine peptides will be administered Vaccine administration will occur on Days 1, 4, 8, and 15 during Cycle 1 and on Day 1 of Cycles 2, 5, and 8 Patients in clinically stable condition who are considered by the investigator to be deriving clinical benefit may continue therapy after disease progression
Procedure : Biopsy
Experimental Personalized Vaccine + Pembrolizumab
Surgical or core needle biopsy of an accessible site for sequence analysis to generate the personalized vaccine 6 weeks following enrollment (approximately 9 weeks following the last dose of systemic chemotherapy), a repeat CT scan will be done to document disease stability. Should disease progression be evident, patients will begin pembrolizumab until the personalized vaccine is available All patients will begin treatment with pembrolizumab on a 21-day cycle for up to a maximum of 2 years of therapy 12 weeks after enrollment Up to 2 doses of pembrolizumab can be given prior to vaccine preparation if there is a delay in vaccine formulation. Up to 20 personalized vaccine peptides will be administered Vaccine administration will occur on Days 1, 4, 8, and 15 during Cycle 1 and on Day 1 of Cycles 2, 5, and 8 Patients in clinically stable condition who are considered by the investigator to be deriving clinical benefit may continue therapy after disease progression
Drug : Poly ICLC
Experimental Personalized Vaccine + Pembrolizumab
Surgical or core needle biopsy of an accessible site for sequence analysis to generate the personalized vaccine 6 weeks following enrollment (approximately 9 weeks following the last dose of systemic chemotherapy), a repeat CT scan will be done to document disease stability. Should disease progression be evident, patients will begin pembrolizumab until the personalized vaccine is available All patients will begin treatment with pembrolizumab on a 21-day cycle for up to a maximum of 2 years of therapy 12 weeks after enrollment Up to 2 doses of pembrolizumab can be given prior to vaccine preparation if there is a delay in vaccine formulation. Up to 20 personalized vaccine peptides will be administered Vaccine administration will occur on Days 1, 4, 8, and 15 during Cycle 1 and on Day 1 of Cycles 2, 5, and 8 Patients in clinically stable condition who are considered by the investigator to be deriving clinical benefit may continue therapy after disease progression
Procedure : Leukapheresis
Experimental Personalized Vaccine + Pembrolizumab
Surgical or core needle biopsy of an accessible site for sequence analysis to generate the personalized vaccine 6 weeks following enrollment (approximately 9 weeks following the last dose of systemic chemotherapy), a repeat CT scan will be done to document disease stability. Should disease progression be evident, patients will begin pembrolizumab until the personalized vaccine is available All patients will begin treatment with pembrolizumab on a 21-day cycle for up to a maximum of 2 years of therapy 12 weeks after enrollment Up to 2 doses of pembrolizumab can be given prior to vaccine preparation if there is a delay in vaccine formulation. Up to 20 personalized vaccine peptides will be administered Vaccine administration will occur on Days 1, 4, 8, and 15 during Cycle 1 and on Day 1 of Cycles 2, 5, and 8 Patients in clinically stable condition who are considered by the investigator to be deriving clinical benefit may continue therapy after disease progression
Procedure : Peripheral blood draw

Recruitment Information

Recruitment Status:Not yet recruiting
Enrollment20
Completion DateMay 31, 2027
Eligibility Criteria: Inclusion Criteria:
- Histologically confirmed stage IV NSCLC (squamous, adenocarcinoma, or large cell carcinoma) that is stable after four cycles of a platinum doublet. Maintenance chemotherapy is not allowed.
- Sufficient tumor tissue must be available for histologic assessment of PD-L1 expression and whole exome sequencing.
- Measurable disease by RECIST 1.1.
- At least 18 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- Normal bone marrow and organ function as defined below:
- Absolute neutrophil count ≥ 1,500/mcl
- Platelets ≥ 100,000/mcl
- Hemoglobin ≥ 9.0 g/dL
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (IULN) OR
- Direct bilirubin ≤ IULN for patients with total bilirubin > 1.5 x IULN
- AST(SGOT)/ALT(SGPT) ≤ 2.5 x IULN (or ≤ 5 x IULN for patients with liver metastases)
- Albumin ≥ 2.5 mg/dL
- Serum creatinine ≤ 1.5 x IULN OR
- Creatinine clearance by Cockcroft-Gault ≥ 60 mL/min/1.73 m2 for patients with creatinine levels > 1.5 x IULN
- INR or PT ≤ 1.5 x IULN unless patient is receiving anticoagulant therapy as long as PT or *PTT is within therapeutic range of intended use of anticoagulants
- aPTT ≤ 1.5 x IULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
- Sexually active women of childbearing potential and men must agree to use 2 methods of contraception (hormonal or barrier method of birth control, abstinence) prior to study entry, for the duration of study participation, and for 120 days after last dose of pembrolizumab. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
- Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Exclusion Criteria:
- Treatment with an anti-cancer monoclonal antibody within 4 weeks prior to Day 1 or has not recovered (i.e., ≤ grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
- Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ grade 1 or at baseline) from adverse events due to a previously administered agent. Note: subjects with ≤ grade 2 neuropathy are an exception to this criterion and may qualify for the study. Note: if subject received major surgery, s/he must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to Day 1.
- Prior treatment with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
- Prior treatment with a cancer vaccine.
- Prior treatment with an anti-CTLA-4 agent
- Received a live vaccine within 30 days prior to Day 1.
- Known active central nervous system (CNS) 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 Day 1 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 trial treatment. This exception does not include carcinomatous meningitis, which is excluded regardless of clinical stability.
- Currently receiving any other investigational agents or has participated in a study of an investigational agent or using an investigational device within 4 weeks prior to Day 1.
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to pembrolizumab or other agents used in the study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring systemic therapy, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, underlying pulmonary disease, or psychiatric illness/social situations that would limit compliance with study requirements.
- Has an active autoimmune disease requiring systemic treatment within the past 2 years (i.e. with use of disease modifying agents, corticosteroids (prednisone dose of 5 mg or less per day is allowed), or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Known history of, or any evidence of active, non-infectious pneumonitis.
- Pregnant and/or breastfeeding. Patient must have a negative serum or urine pregnancy test within 72 hours of study entry.
- Known active hepatitis B (e.g., HBsAg reactive) or hepatitis C (e.g., HCV RNA [qualitative] is detected).
- Known history of active tuberculosis (TB)
- Known history of HIV (HIV 1/2 antibodies).
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
United States

Administrative Information

NCT Number:NCT03166254
Other Study ID Numbers
201707041
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Washington University School of Medicine
Collaborators
Not Available
Investigators
Principal Investigator
Ramaswamy Govindan, M.D.
Washington University School of Medicine