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A Phase Ib Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) of Avelumab in Combination With M9241(NHS-IL12) (JAVELIN IL-12) (COMBO)

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ClinicalTrials.gov Identifier: NCT02994953
Recruitment Status : Recruiting
First Posted : December 16, 2016
Last Update Posted : November 20, 2018
Sponsor:
Collaborator:
Merck KGaA, Darmstadt, Germany
Information provided by (Responsible Party):
EMD Serono ( EMD Serono Research & Development Institute, Inc. )

Brief Summary:
The study consists of 2 parts: Dose Escalation phase (Part A) and Expansion phase (Part B). The dose escalation phase will evaluate the safety, tolerability, and PK of avelumab in combination with NHS-IL12 in subjects with locally advanced, unresectable, or metastatic solid tumors. Expansion phase will assess the safety and clinical activity of the combination regimen in selected tumor types. In Expansion phase subjects who have completed the combination treatment of avelumab at a given dose level of NHS-IL12, a safety review will be performed by the Safety monitoring committee in order to make a decision on the next dose level. Successive cohorts of 3 to 6 subjects will be treated with escalating doses of NHS-IL12 with avelumab intravenous (IV).

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: Avelumab Drug: NHS-IL12 Drug: Avelumab (Once weekly) Drug: NHS-IL12 (MTD) Drug: Avelumab (Expansion cohort) Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 185 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ib Open‑Label, Dose‑Finding Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Avelumab in Combination With M9241(NHS-IL12) in Subjects With Locally Advanced, Unresectable, or Metastatic Solid Tumors
Actual Study Start Date : January 31, 2017
Estimated Primary Completion Date : January 20, 2020
Estimated Study Completion Date : January 20, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Avelumab and NHS-IL12 Drug: Avelumab
Subjects will receive avelumab intravenous (IV) infusion once a week on Day 1 and Day 15 of each cycle.
Other Name: MSB0010718C

Drug: NHS-IL12
Subjects will receive Subcutaneous (SC) injection of NHS-IL12 in escalating doses on Day 1 of each cycle.

Experimental: Avelumab (once weekly) + NHS-IL 12 (MTD) Drug: Avelumab (Once weekly)
Subjects will receive avelumab once weekly in combination with NHS-IL12 at NHS-IL12 maximum tolerated dose (MTD) for first 12 weeks followed by avelumab once every 2 weeks plus NHS-IL12 at NHS-IL12 MTD until treatment discontinuation.

Drug: NHS-IL12 (MTD)
Subjects will receive NHS-IL12 at NHS-IL12 MTD once every 4 weeks until treatment discontinuation.

Experimental: Avelumab (once weekly) + NHS-IL 12 (MTD) (Expansion cohort) Drug: Avelumab (Expansion cohort)
Subjects in the expansion cohorts will receive avelumab according to the avelumab + NHS-IL12 recommended Phase II dose (RP2D) on Day 1 of each treatment cycle.




Primary Outcome Measures :
  1. Part A and B: Occurrence and Severity of Treatment Emergent Adverse Events (TEAEs) and related TEAEs [ Time Frame: Up to 222 Weeks ]
  2. Part A: Number of Subjects With Dose Limiting Toxicities (DLTs) [ Time Frame: Up to 3 weeks ]
  3. Part A: Duration of TEAEs and Related TEAEs [ Time Frame: Up to 52 weeks ]
  4. Part B: Best Overall Response (BOR) by Investigator Assessment [ Time Frame: Up to 222 weeks ]

Secondary Outcome Measures :
  1. Part A: Area Under the Concentration Time Curve from time of dosing to the time of the last observation (AUC0-t) of Avelumab [ Time Frame: Pre-dose, 1, 4, 8 hours post-infusion (Day 1, 15); Day 2, 3, 8, 11 post-infusion ]
  2. Part A: Area Under the Concentration Time Curve from time of dosing to infinity (AUC0-inf) of Avelumab [ Time Frame: Pre-dose, 1, 4, 8 hours post-infusion (Day 1, 15); Day 2, 3, 8, 11 post-infusion ]
  3. Part A: Terminal Elimination Rate Constant (λz) of Avelumab [ Time Frame: Pre-dose, 1, 4, 8 hours post-infusion (Day 1, 15); Day 2, 3, 8, 11 post-infusion ]
  4. Part A: Maximum Serum Concentration (Cmax) of Avelumab [ Time Frame: Pre-dose, 1, 4, 8 hours post-infusion (Day 1, 15); Day 2, 3, 8, 11 post-infusion ]
  5. Part A: Minimum Serum Concentration (Cmin) of Avelumab [ Time Frame: Pre-dose, 1, 4, 8 hours post-infusion (Day 1, 15); Day 2, 3, 8, 11 post-infusion ]
  6. Part A: Time to Reach Maximum Concentration Cmax (Tmax) of Avelumab [ Time Frame: Pre-dose, 1, 4, 8 hours post-infusion (Day 1, 15); Day 2, 3, 8, 11 post-infusion ]
  7. Part A: Apparent Terminal Half-life (t1/2) of Avelumab [ Time Frame: Pre-dose, 1, 4, 8 hours post-infusion (Day 1, 15); Day 2, 3, 8, 11 post-infusion ]
  8. Part A: AUC From the Time of Dosing to the Dosing Interval Tau (AUCtau) of Avelumab [ Time Frame: Pre-dose, 1, 4, 8 hours post-infusion (Day 1, 15); Day 2, 3, 8, 11 post-infusion ]
  9. Part A: Area Under the Concentration Time Curve from time of dosing to the time of the last observation (AUC0-t) of NHS-IL12 [ Time Frame: Pre-dose, 1, 4, 8 hours post-infusion (Day 1); Day 2, 3, 8, 11 post-infusion ]
  10. Part A: Area Under the Concentration Time Curve from time of dosing to infinity (AUC0-inf) of NHS-IL12 [ Time Frame: Pre-dose, 1, 4, 8 hours post-infusion (Day 1); Day 2, 3, 8, 11 post-infusion ]
  11. Part A: Terminal Elimination Rate Constant (λz) of NHS-IL12 [ Time Frame: Pre-dose, 1, 4, 8 hours post-infusion (Day 1); Day 2, 3, 8, 11 post-infusion ]
  12. Part A: Maximum Serum Concentration (Cmax) of NHS-IL12 [ Time Frame: Pre-dose, 1, 4, 8 hours post-infusion (Day 1); Day 2, 3, 8, 11 post-infusion ]
  13. Part A: Minimum Serum Concentration (Cmin) of NHS-IL12 [ Time Frame: Pre-dose, 1, 4, 8 hours post-infusion (Day 1); Day 2, 3, 8, 11 post-infusion ]
  14. Part A: Time to Reach Maximum Concentration Cmax (Tmax) of NHS-IL12 [ Time Frame: Pre-dose, 1, 4, 8 hours post-infusion (Day 1); Day 2, 3, 8, 11 post-infusion ]
  15. Part A: Apparent Terminal Half-life (t1/2) of NHS-IL12 [ Time Frame: Pre-dose, 1, 4, 8 hours post-infusion (Day 1); Day 2, 3, 8, 11 post-infusion ]
  16. Part A: AUC From the Time of Dosing to the Dosing Interval Tau (AUCtau) of NHS-IL12 [ Time Frame: Pre-dose, 1, 4, 8 hours post-infusion (Day 1); Day 2, 3, 8, 11 post-infusion ]
  17. Part A: Immunogenicity of Avelumab and NHS-IL12 Measured by ADA Assays [ Time Frame: At screening and Pre-dose at Day 15 ]
  18. Part A: Confirmed Best Overall Response (BOR) According to RECIST v1.1 Criteria [ Time Frame: Up to 52 weeks ]
  19. Part A: Immune-related BOR Using Immune-related Response Criteria, Derived From RECIST v1.1 [ Time Frame: Up to 52 weeks ]
  20. Part B: Progression Free Survival (PFS) According to RECIST v1.1 Criteria Assessed by Investigator [ Time Frame: Baseline until progressive disease or death, assessed up to 222 weeks ]
  21. Part B: Overall Survival (OS) [ Time Frame: Baseline until death, assessed up to 222 weeks ]
  22. Part B: Duration of Response According to RECIST v1.1 Criteria Assessed by Investigator [ Time Frame: Baseline until 222 weeks ]
  23. Part B: Area Under the Concentration Time Curve from time of dosing to the time of the last observation (AUC0-t) of Avelumab and NHS-IL12 [ Time Frame: Pre-dose, 1 h post-infusion on Day 1 Cycle 1, Day 15 Cycle 1, Day 1 Cycle 2, 3, 4 and Day 3 Cycle 1, 2, 3, 4 (each cycle = 28 days) ]
  24. Part B: Area Under the Concentration Time Curve From Time of Dosing to Infinity (AUC0-inf) of Avelumab and NHS-IL12 [ Time Frame: Pre-dose, 1 h post-infusion on Day 1 Cycle 1, Day 15 Cycle 1, Day 1 Cycle 2, 3, 4 and Day 3 Cycle 1, 2, 3, 4 (each cycle = 28 days) ]
  25. Part B: Terminal Elimination Rate Constant (λz) of Avelumab and NHS-IL12 [ Time Frame: Pre-dose, 1 h post-infusion on Day 1 Cycle 1, Day 15 Cycle 1, Day 1 Cycle 2, 3, 4 and Day 3 Cycle 1, 2, 3, 4 (each cycle = 28 days) ]
  26. Part B: Maximum Serum Concentration (Cmax) of Avelumab and NHS-IL12 [ Time Frame: Pre-dose, 1 h post-infusion on Day 1 Cycle 1, Day 15 Cycle 1, Day 1 Cycle 2, 3, 4 and Day 3 Cycle 1, 2, 3, 4 (each cycle = 28 days) ]
  27. Part B: Minimum Serum Concentration (Cmin) of Avelumab and NHS-IL12 [ Time Frame: Pre-dose, 1 h post-infusion on Day 1 Cycle 1, Day 15 Cycle 1, Day 1 Cycle 2, 3, 4 and Day 3 Cycle 1, 2, 3, 4 (each cycle = 28 days) ]
  28. Part B: Time to Reach Maximum Concentration Cmax (Tmax) of Avelumab and NHS-IL12 [ Time Frame: Pre-dose, 1 h post-infusion on Day 1 Cycle 1, Day 15 Cycle 1, Day 1 Cycle 2, 3, 4 and Day 3 Cycle 1, 2, 3, 4 (each cycle = 28 days) ]
  29. Part B: Apparent Terminal Half-life (t1/2) of Avelumab and NHS-IL12 [ Time Frame: Pre-dose, 1 h post-infusion on Day 1 Cycle 1, Day 15 Cycle 1, Day 1 Cycle 2, 3, 4 and Day 3 Cycle 1, 2, 3, 4 (each cycle = 28 days) ]
  30. Part B: AUC From the Time of Dosing to the Dosing Interval Tau (AUCtau) of Avelumab and NHS-IL12 [ Time Frame: Pre-dose, 1 h post-infusion on Day 1 Cycle 1, Day 15 Cycle 1, Day 1 Cycle 2, 3, 4 and Day 3 Cycle 1, 2, 3, 4 (each cycle = 28 days) ]
  31. Part B: Immunogenicity of Avelumab and NHS-IL12 Measured by ADA Assays. [ Time Frame: Pre-dose at Day 1 and Day 15 of Cycle 1, Pre-dose at Day 1 of Cycle 2 ,3 and 4 (each cycle = 28 days) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Part A:

  • Subjects must have signed written informed consent.
  • Male or female subjects age greater than equals to (>=)18 years.
  • Subjects must have histologically or cytologically proven metastatic or locally advanced solid tumors for which no standard therapy exists, standard therapy has failed, subject is intolerant of established therapy known to provide clinical benefit for their condition, or standard therapy is not acceptable to the subject.
  • Subjects who have been treated previously with a checkpoint inhibitor may enroll (except as outlined below for expansion cohorts).
  • At least 1 unidimensional radiographically measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1), except for subjects with metastatic castration-resistant prostate cancer (CRPC) or metastatic breast cancer who may be enrolled with objective evidence of disease without a measureable lesion.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at Screening
  • Estimated life expectancy of more than 12 weeks
  • Adequate hematological function as defined below:

    • White blood cells (WBC) count >= 3.0 × 10^9 per liter (/L)
    • Absolute neutrophil count >= 1.5 × 10^9/L
    • Lymphocyte count >= 0.5 × 10^9/L
    • Platelet count >= 100 × 10^9/L
    • Hemoglobin >= 9 gram per deciliter (g/dL) (may have been transfused)
  • Adequate hepatic function as defined below:

    • A total bilirubin level lass than equals to (<=) 1.5 × the upper limit of normal (ULN) range • Aspartate aminotransferase (AST) levels <= 2.5 × ULN (≤ 3 × ULN for expansion cohorts)
    • Alanine aminotransferase (ALT) levels <= 2.5 × ULN (≤ 3 × ULN for expansion cohorts)
    • Subjects with documented Gilbert disease are allowed if total bilirubin > 1.5 but less than 3 × ULN
  • Adequate renal function as defined by an estimated creatinine clearance >= 50 milliliter per minute (mL/min) according to the Cockcroft-Gault formula
  • Negative blood pregnancy test at Screening for women of childbearing potential. For the purposes of this trial, women of childbearing potential are defined as all female subjects after puberty unless they are postmenopausal for at least 1 year, are surgically sterile or are sexually inactive.
  • Highly effective contraception (ie, methods with a failure rate of less than 1% per year) must be used before the start of treatment, for the duration of the trial treatment, and for at least 50 days after stopping study treatment for both men and women if the risk of conception exists. The effects of avelumab and NHS-IL12 on the developing human fetus are unknown; thus, women of childbearing potential and men must agree to use highly effective contraception.

Part B:

  • Urothelial carcinoma (UC) post-platinum: Histologically or cytologically confirmed locally advanced or metastatic transitional cell carcinoma of the urothelium (including renal pelvis, ureters, urinary bladder, and urethra). Subjects must have progressed after treatment with at least 1 platinum containing regimen for inoperable locally advanced or metastatic UC or disease recurrence. Availability of either tumor archival material (< 6 months old)or fresh biopsies (obtained within 28 days) is acceptable with one of these being mandatory. For formalin-fixed paraffin-embedded samples, either block or sections (> 15) may be provided. Tumor biopsies and tumor archival material must be suitable for biomarker assessment.
  • Non-small cell lung cancer (NSCLC), first-line metastatic: Stage IV (per seventh International Association for the Study of Lung Cancer classification) histologically confirmed NSCLC. Subjects must not have received treatment for their metastatic disease. Subjects could have received adjuvant chemotherapy or loco-regional treatment that included chemotherapy for locally advanced disease, as long as disease recurrence occurred at least 6 months after the completion of the last administration of chemotherapy. Only epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type are allowed (ie, EGFR mutation and ALK translocation / re arrangement excluded). Non squamous cell histologies and never / former light smoker (< 15 pack years) squamous cell carcinoma subjects (per local standard of care) require testing if status is unknown. Subjects must have low tumor PD-L1 expression defined as < 50% tumor proportion score determined using PD-L1 IHC 22C3 pharmDx test or an equivalent Food and Drug Administration (FDA)- approved PD-L1 test. Availability of either tumor archival material or fresh biopsies within 28 days is acceptable with one of these being mandatory. For FFPE samples, either block or sections (> 15) may be provided. Tumor biopsies and tumor archival material must be suitable for biomarker assessment. This cohort will not be opened for enrollment in Belgium, Czech Republic, Germany, Hungary, Italy, Netherlands, Spain, and United Kingdom.
  • Colorectal cancer (CRC): Histologically or cytologically confirmed recurrent or refractory metastatic CRC (according to American Joint Committee on Cancer / International Union Against Cancer Tumor Node Metastasis [TNM] Staging System seventh edition) after failure of prior therapy containing oxaliplatin / fluoropyrimidine and / or irinotecan / fluoropyrimidine and, if eligible, cetuximab (Erbitux®) and bevacizumab (Avastin®). Only subjects with microsatellite instability (MSI)-low or microsatellite stable (MSS) metastatic CRC are eligible. Subjects without existing MSI test results will have MSI status performed locally by a Clinical Laboratory Improvement Amendments (CLIA)-certified IHC or polymerase chain reaction (PCR)-based test (PCR based MSI test is preferred). Subjects must be willing to undergo an on-treatment biopsy procedure. Availability of either tumor archival material or fresh biopsies within 28 days is acceptable with one of these being mandatory. For FFPE samples, either block or sections (> 15) may be provided. Tumor biopsies and tumor archival material must be suitable for biomarker assessment. For Belgium, Czech Republic, Germany, Hungary, Italy, Netherlands, Spain, and United Kingdom, subjects in the second-line setting should have exhausted or be considered ineligible or intolerant (in the opinion of the Investigator) of available second-line chemotherapy options.
  • Renal cell carcinoma (RCC), primary immune checkpoint inhibitor failure: Histologically or cytologically documented metastatic RCC with a component of clear cell subtype. Subjects must have had progressive disease (PD) within 6 months or best overall response of stable disease (SD) for ≥ 6 months following start of therapy with any antibody / drug targeting T cell co-regulatory proteins (immune checkpoints) such as anti-PD-1, anti-PD-L1, or anticytotoxic T lymphocyte antigen-4 (CTLA-4) for advanced or metastatic disease (either as monotherapy or combination therapy, in any line). Availability of a fresh tumor biopsy is mandatory for eligibility in the RCC cohort. The biopsy or surgical specimen should be collected within 28 days prior to the first IMP administration. Subjects must also be willing to undergo an on-treatment biopsy procedure.

Exclusion Criteria:

  • Concurrent treatment with a non-permitted drug/intervention (listed below)

    • Anticancer treatment (eg, cytoreductive therapy, radiotherapy, immune therapy, cytokine therapy, monoclonal antibody, targeted small molecule therapy) or any investigational drug within 4 weeks or 5 half-lives, whichever is shorter, prior to start of trial treatment, or not recovered from adverse event (AE) related to such therapies, with the following exceptions: Palliative radiotherapy delivered in a normal organ-sparing technique is permitted; Erythropoietin and darbepoetin-α are permitted; Hormonal therapies acting on the hypothalamic-pituitary-gonadal axis are permitted (i.e. luteinizing hormone-releasing hormone agonist/antagonists). No other hormonal anticancer therapy is permitted.
    • Major surgery (as deemed by Investigator) for any reason, except diagnostic biopsy, within 4 weeks prior to start of trial treatment, or not fully recovered from surgery within 4 weeks prior to start of trial treatment
    • Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before start of trial treatment, with the following exceptions: Subjects with adrenal insufficiency, may continue corticosteroids at physiologic replacement dose, equivalent to ≤ 10 mg prednisone daily; Administration of steroids through a route known to result in a minimal systemic exposure (topical, intranasal, intra-ocular, or inhalation) is permitted; Previous or ongoing administration of systemic steroids for the management of an acute allergic phenomenon is acceptable as long as it is anticipated that the administration of steroids will be completed in 14 days, or that the dose after 14 days will be equivalent to <= 10 mg prednisone daily.
  • Any prior treatment with any form of interlukin-12 (IL-12)
  • For the NSCLC, CRC, and UC expansion cohorts, prior therapy with any antibody / drug targeting T-cell co-regulatory proteins (immune checkpoints) such as anti-PD-1, anti-PD-L1, or anticytotoxic T lymphocyte antigen-4 (CTLA-4) antibody is prohibited.
  • Intolerance to checkpoint inhibitor therapy, as defined by the occurrence of an AE requiring drug discontinuation.
  • Active or history of primary or metastatic central nervous system tumors
  • Prior organ transplantation, including allogeneic stem-cell transplantation
  • Previous malignant disease (other than the indication for this trial) within the last 5 years (except adequately treated non-melanoma skin cancers, carcinoma in situ of skin, bladder, cervix, colon/rectum, breast, or prostate) unless a complete remission without further recurrence was achieved at least 2 years prior to trial entry and the subject was deemed to have been cured with no additional therapy required or anticipated to be required.
  • Significant acute or chronic infections requiring systemic therapy including, among others:

    • History of testing positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome
    • Hepatitis B or C infection (HBV surface antigen positive and HBV core antibody positive with reflex to positive HBV deoxy ribonucleic acid (DNA) or HBV core antibody positive alone with reflex to positive HBV DNA or positive hepatitis C virus [HCV] antibody with reflex to positive HCV ribonucleic acid [RNA]). Subjects with history of infection must have polymerase chain reaction documentation that infection is cleared.
  • Active or history of autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent. Subjects with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible if they are stable on other medical treatment and do not fulfill exclusion criterion including Uncontrolled intercurrent illness
  • Known severe hypersensitivity reactions to monoclonal antibodies (Grade>= 3 National Cancer Institute-Common Terminology Criteria for Adverse Event (NCI-CTCAE) v4.03, or uncontrolled asthma (ie, 3 or more features of partially controlled asthma)
  • History of allergic reaction to methotrexate (trace methotrexate may be present in NHS-IL12 as a part of the manufacturing process) or history of severe hypersensitivity reaction to any other ingredient of the study drug(s) and / or their excipients. Since NHS-IL12 contains sucrose as an excipient, subjects suffering from hereditary fructose intolerance are also excluded
  • Persisting toxicity related to prior therapy of Grade > 1 NCI-CTCAE v4.03 with the following exceptions:

    • Neuropathy Grade <= 2 is acceptable.
    • All grades of alopecia are acceptable.
    • Endocrine dysfunction on replacement therapy is acceptable.
  • Pregnancy or lactation
  • Known alcohol or drug abuse as deemed by the Investigator
  • Uncontrolled intercurrent illness including, but not limited to:

    • Hypertension uncontrolled by standard therapies (not stabilized to 150/90 millimeter of mercury (mm Hg) or lower)
    • Uncontrolled active infection
    • Uncontrolled diabetes (eg, glycosylated hemoglobin [HgbA1c] >= 8%)
  • Clinically significant (or active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class >= II), or serious cardiac arrhythmia requiring medication
  • All other significant diseases (eg, inflammatory bowel disease, current severe acute or chronic colitis) or chronic medical conditions (including laboratory abnormalities) that in the opinion of the Investigator might impair the subject's tolerance of trial treatment or interpretation of trial results.
  • Any psychiatric condition that would prohibit the understanding or rendering of informed consent or that would limit compliance with trial requirements.
  • Legal incapacity or limited legal capacity.
  • Administration of a live vaccine within 30 days prior to trial entry.
  • Any subject with possible area of ongoing necrosis (non-disease related), such as active ulcer, non-healing wound, or intercurrent bone fracture that may be at risk of delayed healing due to protocol therapy.
  • Oxygen saturation < 90% at rest, known pulmonary fibrosis, or active interstitial lung disease.
  • History of congenital or active immunodeficiency, with the exception of acquired treatment-related hypogammaglobulinemia requiring periodic IV immunoglobulin infusion.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02994953


Contacts
Contact: US Medical Information 888-275-7376 service@emdgroup.com

Locations
United States, California
California Cancer Associates for Research & Excellence, Inc. Not yet recruiting
San Diego, California, United States, 92111
Sharp Memorial Hospital Not yet recruiting
San Diego, California, United States, 92123
St Joseph Heritage Healthcare Not yet recruiting
Santa Rosa, California, United States, 95403
United States, Connecticut
Yale University Institutional Review Board Recruiting
New Haven, Connecticut, United States, 06520
United States, Florida
Holy Cross Hospital Inc. Not yet recruiting
Fort Lauderdale, Florida, United States, 33308
Hematology - Oncology Associates of the Treasure Coast Not yet recruiting
Port Saint Lucie, Florida, United States, 34952
United States, Louisiana
Metairie Oncologists, LLC Not yet recruiting
Metairie, Louisiana, United States, 70006
United States, Maryland
National Cancer Institute Recruiting
Bethesda, Maryland, United States, 20892
United States, Minnesota
Virginia Piper Cancer Institute Not yet recruiting
Minneapolis, Minnesota, United States, 55407
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
United States, Ohio
UC Health, LLC. Not yet recruiting
Cincinnati, Ohio, United States, 45229
United States, Oklahoma
University of Oklahoma Health Sciences Center Not yet recruiting
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Cedar Sinai Medical Center Not yet recruiting
Ashland, Oregon, United States, 97520
United States, South Carolina
Medical University of South Carolina Not yet recruiting
Charleston, South Carolina, United States, 29425
United States, Texas
Mary Crowley Cancer Research Centers Not yet recruiting
Dallas, Texas, United States, 75251
United States, Vermont
University of Vermont Medical Center Not yet recruiting
Burlington, Vermont, United States, 05405
United States, Washington
Northwest Medical Specialties, PLLC Not yet recruiting
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
EMD Serono Research & Development Institute, Inc.
Merck KGaA, Darmstadt, Germany
Investigators
Study Director: Medical Responsible EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany

Responsible Party: EMD Serono Research & Development Institute, Inc.
ClinicalTrials.gov Identifier: NCT02994953     History of Changes
Other Study ID Numbers: MS201781_0031
2017-002212-13 ( EudraCT Number )
First Posted: December 16, 2016    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by EMD Serono ( EMD Serono Research & Development Institute, Inc. ):
Avelumab
M9241
NHS-IL12
Advanced Solid Tumors

Additional relevant MeSH terms:
Antibodies, Monoclonal
Interleukin-12
Immunoglobulin G
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents