Clinical Trial - NCT02834247

A Study of TAK-659 in Combination With Nivolumab in Participants With Advanced Solid Tumors

Completed

Sponsor: Millennium Pharmaceuticals, Inc.

Collaborators:

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT02834247

Protocol Info

Short Description: Phase 1b TAK-659 with Nivolumab in Advanced Solid Tumors
Long Description: A Phase 1b Study to Evaluate TAK-659 in Combination With Nivolumab in Patients With Advanced Solid Tumors
MGH Status: Closed
Sponsor: Takeda
Disease Program: Phase I

Next Steps


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Purpose

The purpose of this study is to evaluate the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D), safety and efficacy of TAK-659 in combination with nivolumab in participants with advanced solid tumors.
Condition Title Intervention Phase
Triple-Negative Breast Neoplasms Carcinoma, Non-Small-Cell Lung Head and Neck Carcinoma, Squamous Cell Advanced Solid Tumors TAK-659 Nivolumab Phase 1
Study Type Interventional
Official Title A Phase 1b Study to Evaluate TAK-659 in Combination With Nivolumab in Patients With Advanced Solid Tumors

Primary Outcome Measures

Part 1: Maximum Tolerated Dose (MTD) [Time Frame: Part 1: Cycle 1, Day 1 up to Cycle 1, Day 28] [Designated as safety issue: ]

Part 1: RP2D [Time Frame: Part 1: Cycle 1, Day 1 up to 6 months] [Designated as safety issue: ]

Part 2: Overall Response Rate (ORR) [Time Frame: Part 2: Baseline up to 6 months after the last dose of study treatment (approximately 18 months)] [Designated as safety issue: ]


Secondary Outcome Measures

Percentage of Participants Experiencing 1 or More Treatment-Emergent Adverse Events (TEAEs) [Time Frame: Baseline through 28 days after the last dose of study drug or to the start of subsequent alternative anticancer therapy, whichever occurs first (approximately up to 12 months)] [Designated as safety issue: ]

Percentage of Participants with 1 or More Grade 3 and Grade 4 Adverse Events (AEs) [Time Frame: Baseline through 28 days after the last dose of study drug or to the start of subsequent alternative anticancer therapy, whichever occurs first (approximately up to 12 months)] [Designated as safety issue: ]

Percentage of Participants Experiencing Serious Adverse Events (SAEs) [Time Frame: Baseline through 28 days after the last dose of study drug or to the start of subsequent alternative anticancer therapy, whichever occurs first (approximately up to 12 months)] [Designated as safety issue: ]

Percentage of Participants With TEAEs Resulting in Study Drug Discontinuation [Time Frame: Baseline through 28 days after the last dose of study drug or to the start of subsequent alternative anticancer therapy, whichever occurs first (approximately up to 12 months)] [Designated as safety issue: ]

Number of Participants With Clinically Significant Laboratory Values [Time Frame: Baseline through 28 days after the last dose of study drug or to the start of subsequent alternative anticancer therapy, whichever occurs first (approximately up to 12 months)] [Designated as safety issue: ]

Number of Participants with Clinically Significant Vital Sign Measurements [Time Frame: Baseline through 28 days after the last dose of study drug or to the start of subsequent alternative anticancer therapy, whichever occurs first (approximately up to 12 months)] [Designated as safety issue: ]

Part 2: Percentage of Participants With Disease Control [Time Frame: Part 2: Baseline up to 6 months after the last dose of study treatment (approximately 18 months)] [Designated as safety issue: ]

Part 2: Duration of Response (DOR) [Time Frame: From first dose until discontinuation of study drug due to disease progression, unacceptable toxicity, withdrawal due to other reasons, study is terminated by the sponsor, completion of study, or death (approximately 18 months)] [Designated as safety issue: ]

Part 2: Percentage of Participants With Progression Disease (PD) at Month 6 [Time Frame: Part 2: Month 6] [Designated as safety issue: ]

Part 2: Progression Free Survival (PFS) [Time Frame: Baseline up to 6 months after the last dose of study treatment (approximately 18 months)] [Designated as safety issue: ]

Part 2: Overall Survival (OS) [Time Frame: Baseline up to 12 months after the last dose of study treatment (approximately 24 months)] [Designated as safety issue: ]

Part 1: Maximum Observed Plasma Concentration (Cmax) for TAK-659 [Time Frame: Part 1: Cycle 1: Days 1 and 15: predose and at multiple time points (up to 24 hours) after dosing] [Designated as safety issue: ]

Part 1: Time to Reach the Cmax (Tmax) for TAK-659 [Time Frame: Part 1: Cycle 1: Days 1 and 15: predose and at multiple time points (up to 24 hours) after dosing] [Designated as safety issue: ]

Part 1: Area Under the Plasma Concentration for TAK-659-time Curve from Time 0 to Time tau (AUC tau) [Time Frame: Part 1: Cycle 1: Days 1 and 15: predose and at multiple time points (up to 24 hours) after dosing] [Designated as safety issue: ]

Estimated Enrollment: 41
Study Start Date: July 2016
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2018
Arms Assigned Interventions

Experimental:Part 1: Advanced Solid Tumors

TAK-659 60 milligram (mg), tablets, orally, once daily in each 28-day treatment cycle in combination with nivolumab 3 milligram per kilogram (mg/kg), infusion over 60 minutes, intravenously (IV), on Days 1 and 15 in each 28 day treatment cycle until PD or unacceptable toxicity. Dose escalation of TAK-659 to 100 mg may be done using a 3 + 3 dose escalation design to determine a maximum tolerated dose (MTD) and/or RP2D.
Drug:Nivolumab
Nivolumab intravenous infusion

Experimental:Nivolumab Fixed Dose Cohort

After RP2D of TAK-659 has been identified, based on evaluation of combination with weight-based dose of nivolumab (3 mg/kg), RP2D may be evaluated in combination with a fixed dose of 240 mg IV nivolumab after discussion between investigator and sponsor for all types of advanced solid tumors. For single-agent nivolumab, fixed dose is expected to have equal exposure, safety, and efficacy as weight-based (3 mg/kg) dose. If nivolumab fixed dose is evaluated with TAK-659 RP2D, 3 participants will be initially enrolled into cohort. Following evaluation of safety, efficacy, and any available PK data, along with discussions between investigator and sponsor, 3 additional participants may be enrolled into cohort for a total of 3 to 6 participants. If >=1 out of 6 participants experiences dose-limiting toxicity (DLT) in Cycle 1, or significant safety issues are seen in Cycle 2 and beyond, re-evaluation of TAK-659 RP2D when administered with a fixed dose of nivolumab is permitted.

Experimental:Part 2: Metastatic Triple-negative Breast Cancer (TNBC)

Participants with metastatic TNBC will receive TAK-659 at the RP2D as determined in Part 1, tablets, orally, once daily in each 28-day treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Day 1 and Day 15 of each 28 day treatment cycle until PD or unacceptable toxicity. A subset of participants will receive two weeks of TAK-659 monotherapy during Cycle 1, and will receive nivolumab beginning on Day 15 of Cycle 1. The dose of nivolumab will be either 3 mg/kg or 240 mg IV, dependent on whether the 240 mg fixed-dose cohort is evaluated and deemed safe and tolerable. If so, the dosing regimen may switch to 240 mg, on the basis of change in clinical practice and discussion between the investigator and sponsor. If the nivolumab fixed-dose evaluation cohort is not run, the dose of nivolumab for all participants in the dose expansion phase will be 3 mg/kg.

Experimental:Part 2: Metastatic Non-small Cell Lung Cancer (NSCLC)

Participants with metastatic NSCLC will receive TAK-659 at the RP2D as determined in Part 1, tablets, orally, once daily in each 28-day treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Day 1 and Day 15 of each 28 day treatment cycle until PD or unacceptable toxicity. A subset of participants will receive two weeks of TAK-659 monotherapy during Cycle 1, and will receive nivolumab beginning on Day 15 of Cycle 1.disease or unacceptable toxicity. The dose of nivolumab will be either 3 mg/kg or 240 mg IV, dependent on whether the 240 mg fixed-dose cohort is evaluated and deemed safe and tolerable. If so, the dosing regimen may switch to 240 mg, on the basis of change in clinical practice and discussion between the investigator and sponsor. If the nivolumab fixed-dose evaluation cohort is not run, the dose of nivolumab for all participants in the dose expansion phase will be 3 mg/kg.

Experimental:Part 2: Metastatic HNSCC

Participants with Head and Neck Squamous Cell Carcinoma (HNSCC) will receive TAK-659 at the RP2D as determined in Part 1, tablets, orally, once daily in each 28-day treatment cycle in combination with nivolumab 3 mg/kg, infusion over 60 minutes, intravenously, on Day 1 and Day 15 of each 28 day treatment cycle until PD or unacceptable toxicity. A subset of participants will receive two weeks of TAK-659 monotherapy during Cycle 1, and will receive nivolumab beginning on Day 15 of Cycle 1. The dose of nivolumab will be either 3 mg/kg or 240 mg IV, dependent on whether the 240 mg fixed-dose cohort is evaluated and deemed safe and tolerable. If so, the dosing regimen may switch to 240 mg, on the basis of change in clinical practice and discussion between the investigator and sponsor. If the nivolumab fixed-dose evaluation cohort is not run, the dose of nivolumab for all participants in the dose expansion phase will be 3 mg/kg.

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

Inclusion Criteria:

1. Is a male or female participant aged 18 years or older.

2. Has eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

3. Female participants who:

  • Are postmenopausal for at least 1 year before the Screening visit, or
  • Are surgically sterile, or
  • If childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 180 days after the last dose of study drug, or
  • Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participants. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception.)

Male participants, even if surgically sterilized (that is, status postvasectomy), who:

  • Agree to practice effective barrier contraception during the entire study treatment period and through 180 days after the last dose of study drug, or
  • Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participants. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception.)

4. Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participants at any time without prejudice to future medical care.

5. Suitable venous access for the study-required blood sampling, including PK and pharmacodynamic (PD) sampling.

6. Clinical laboratory values and other measures as specified below within 28 days before the first dose of study drug:

  • Total bilirubin must be <=1.5*the upper limit of normal (ULN).
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) must be <=2.5*ULN.
  • Creatinine clearance must be greater than or equal to (>=) 60 milliliter per (mL/) minute as estimated by the Cockcroft Gault equation or based on urine collection (12 or 24 hours).
  • Hemoglobin must be >=8 gram per deciliter (g/dL), absolute neutrophil count (ANC) must be >=1500 per microliter (/mcL), and platelet count must be >=75,000/mcL.
  • Lipase must be <=1.5*ULN and amylase <=1.5*ULN with no clinical symptoms suggestive of pancreatitis and cholecystitis.
  • Blood pressure <= Grade 1 (hypertensive participants are permitted if their blood pressure is controlled to <= Grade 1 by hypotensive medications and glycosylated HbA1C <= 6.5%).

7. Recovered (that is, <=Grade 1 toxicity) from the reversible effects of prior anticancer therapy.

8. To be enrolled in the dose escalation phase of the study, participants must have a radiographically or clinically evaluable tumor, but measurable disease as defined by RECIST version 1.1 [1] is not required for participation in this study.

9. To be enrolled in the TNBC expansion cohort, participants must have:

  • Histologically confirmed, metastatic TNBC with measurable disease per RECIST version 1.1.
  • Triple-negative disease (estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 (HER2) negativity confirmed on a histological biopsy of a metastatic tumor lesion (receptor conversion not allowed).
  • Safely accessible tumor lesions (based on investigator's assessment) for serial pre treatment and post treatment biopsies are required for participants receiving TAK-659 monotherapy run-in treatment for 2 weeks followed by TAK-659 plus nivolumab combination treatment [ approximately 10/30 response-evaluable participants]; adequate, newly obtained, core or excisional biopsy of a metastatic tumor lesion not previously irradiated is required. Mandatory biopsies will be taken before TAK-659 monotherapy, after the 2 weeks of TAK-659 monotherapy, and after 6 weeks of TAK-659 plus nivolumab combination therapy. An optional biopsy may be taken at PD with additional consent from the participants.
  • One, 2, or 3 prior lines of chemotherapy for metastatic disease and with progression of disease on last treatment regimen.
  • For the purposes of this study, neoadjuvant and/or adjuvant chemotherapy regimens do not count as a prior line of therapy.
  • Prior treatment must include an anthracycline and/or a taxane in the neoadjuvant, adjuvant, or metastatic setting with the exception for participants who are clinically contraindicated for these chemotherapies.

10. To be enrolled in the NSCLC expansion cohort, participants must have:

  • Locally advanced or metastatic (stage IIIB, stage IV, or recurrent) NSCLC with measurable lesions per RECIST version 1.1.
  • PD during or following at least 1 prior treatment. Participants should have received a prior platinum-based 2-drug regimen for locally advanced, unresectable/ inoperable or metastatic NSCLC or disease recurrence within 6 months of treatment with a platinum-based adjuvant/neoadjuvant regimen or combined modality (example, chemoradiation) regimen with curative intent.
  • Participants with epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic alternations should have PD on prior US-FDA approved therapy for these aberrations.
  • Safely accessible tumor lesions (based on investigator's assessment) for serial pretreatment and posttreatment biopsies are required for participants receiving TAK-659 monotherapy run-in treatment for 2 weeks followed by TAK-659 plus nivolumab combination treatment (approximately10/30 response-evaluable participants); adequate, newly obtained, core or excisional biopsy of a metastatic tumor lesion not previously irradiated is required. Mandatory biopsies will be taken before TAK-659 monotherapy, after the 2 weeks of TAK-659 monotherapy, and after 6 weeks of TAK-659 plus nivolumab combination therapy. An optional biopsy may be taken at progression with additional consent from the participants.

11. To be enrolled in the HNSCC expansion cohort, participants must have:

  • Histologically confirmed recurrent or metastatic HNSCC (oral cavity, pharynx, or larynx) that is stage III/IV and not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy).
  • Histologically confirmed recurrent or metastatic squamous cell carcinoma of unknown primary or nonsquamous histologies (example, mucosal melanoma) are not allowed.
  • Histologically confirmed recurrent or metastatic carcinoma of the nasopharynx is allowed, but these participants will not be included as response-evaluable participants for efficacy analysis of HNSCC.
  • Measurable disease per RECIST version 1.1.
  • Tumor progression or recurrence within 6 months of the last dose of platinum-based therapy in the adjuvant (that is, with radiation after surgery), primary (that is, with radiation), recurrent, or metastatic setting.
  • Safely accessible tumor lesions (based on investigator's assessment) for serial pretreatment and posttreatment biopsies are required for participants receiving TAK-659 monotherapy run-in treatment for 2 weeks followed by TAK-659 plus nivolumab combination treatment (approximately 10/30 response-evaluable participants); adequate, newly obtained, core or excisional biopsy of a metastatic tumor lesion not previously irradiated is required. Mandatory biopsies will be taken before TAK-659 monotherapy, after the 2 weeks of TAK-659 monotherapy, and TAK-659 after 6 weeks of TAK-659 plus nivolumab combination therapy. An optional biopsy may be taken at progression with additional consent from the participants.

Exclusion Criteria:

1. Has active brain metastases or leptomeningeal metastases.

2. Has active, or suspected autoimmune disease or a history of known autoimmune disease, with the exception of:

o Participants with vitiligo, type I diabetes mellitus, resolved childhood asthma/atopy, residual hypothyroidism due to autoimmune condition requiring only hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.

3. Any condition requiring systemic treatment with corticosteroids (less than [>]10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 before first dose of study drug.

o Corticosteroids for topical use or in nasal spray are allowed, as are inhaled steroids and adrenal replacement steroid doses >10 mg daily in the absence of active autoimmune disease.

4. Has history of pneumonitis requiring treatment with steroids; history of idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on the Screening chest CT scan; history of radiation pneumonitis in the radiation field (fibrosis) is permitted.

5. Has history of interstitial lung disease.

6. Prior therapy with experimental antitumor vaccines; any T-cell co-stimulation agents or inhibitors of checkpoint pathways, such as anti- programmed cell death protein 1 (PD-1), anti- programmed cell death 1 ligand 1 (PD-L1), anti- programmed cell death 1 ligand 2 (PD-L2), anti-CD137, or anti-CTLA-4 antibody; or other agents specifically targeting T cells are prohibited. However, for dose escalation, prior treatment with the marketed inhibitors of the immune checkpoint pathway, such as nivolumab and pembrolizumab, is allowed. In addition, in each of the expansion cohorts, 6 response-evaluable participants with prior exposure to anti-PD-1 or anti-PD-L1 agents will be allowed to enroll.

7. Has any serious medical or psychiatric illness, including drug or alcohol abuse, that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.

8. Has life-threatening illness unrelated to cancer.

9. Is female participant who are lactating and breast-feeding or a positive serum pregnancy test during the Screening period or a positive urine pregnancy test on Day 1 before the first dose of study drug.

10. Systemic anticancer treatment including investigational agents or radiotherapy <2 weeks before the first dose of study treatment (<4 weeks for antibody-based therapy including unconjugated antibody, antibody-drug conjugate, and bi-specific T-cell engager agents; <=8 weeks for cell-based therapy or antitumor vaccine) or have not recovered from acute toxic effects from prior chemotherapy and radiotherapy.

11. Prior treatment with investigational agents =<21 days or =<5*their half-lives (whichever is shorter) before the first dose of study treatment. A minimum of 10 days should elapse from prior therapy to initiating protocol therapy.

12. Major surgery within 14 days before the first dose of study drug and not recovered fully from any complications from surgery.

13. Systemic infection requiring intravenous antibiotic therapy or other serious infection within 14 days before the first dose of study drug.

14. Known human immunodeficiency virus (HIV) positive (testing not required).

15. Known hepatitis B surface antigen-positive or known or suspected active hepatitis C infection (testing not required).

16. Participants with another malignancy within 2 years of study start. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection and are considered disease-free at the time of study entry.

17. Any clinically significant comorbidities, such as uncontrolled pulmonary disease, known impaired cardiac function or clinically significant cardiac disease (specified below), active central nervous system disease, active infection, or any other condition that could compromise the participant's participation in the study.

Participants with any of the following cardiovascular conditions are excluded:

  • Acute myocardial infarction within 6 months before starting study drug.
  • Current or history of New York Heart Association Class III or IV heart failure
  • Evidence of current uncontrolled cardiovascular conditions including cardiac arrhythmias, angina, pulmonary hypertension, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
  • Fridericia corrected QT interval (QTcF) >450 milliseconds (msec) (men) or >475 msec (women) on a 12-lead electrocardiogram (ECG) during the Screening period.
  • Abnormalities on 12-lead ECG including, but not limited to, changes in rhythm and intervals that in the opinion of the investigator are considered to be clinically significant.

18. Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of TAK-659 including difficulty swallowing tablets; diarrhea >Grade 1 despite supportive therapy.

19. Use or consumption of any of the following substances:

  • Medications or supplements that are known to be inhibitors of P-glycoprotein (P-gp) and/or strong reversible inhibitors of cytochrome P450 (CYP) 3A within 5 times the inhibitor half-life (if a reasonable half-life estimate is known) or within 7 days (if a reasonable half-life estimate is unknown) before the first dose of study drug. In general, the use of these agents is not permitted during the study.
  • Non-oncology vaccine therapies for prevention of infectious diseases (example, human papillomavirus [HPV] vaccine) within 4 weeks of study drug administration. The inactivated seasonal influenza vaccine can be given to participants before treatment and while on therapy without restriction. Influenza vaccines containing live virus or other clinically indicated vaccinations for infectious diseases (example, pneumovax, varicella) may be permitted but must be discussed with the sponsor's medical monitor and may require a washout period before and after administration of vaccine.
  • Medications or supplements that are known to be strong CYP3A mechanism-based inhibitors or strong CYP3A inducers and/or P-gp inducers within 7 days, or within 5 times the inhibitor or inducer half-life (whichever is longer), before the first dose of study drug. The use of these agents is not permitted during the study.
  • Grapefruit-containing food or beverages within 5 days before the first dose of study drug. Note that grapefruit-containing food and beverages are prohibited during the study.

20. For dose expansion participants who will have tumor biopsies collected:

  • ECOG performance status >1.
  • Activated partial thromboplastin time (aPTT) or plasma thromboplastin (PT) outside the institution's standard of care.
  • Platelet count <75,000/mcL.
  • Known bleeding diathesis or history of abnormal bleeding, or any other known coagulation abnormalities that would contraindicate the tumor biopsy procedure.
  • Ongoing therapy with any anticoagulant or antiplatelet agents (example, aspirin, clopidogrel, coumadin, heparin, or warfarin) that cannot be held to permit tumor biopsy).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT02834247

Locations

  • United States, California
    • UCSD La Jolla, California, United States, 92093
  • United States, Georgia
    • Emory Atlanta, Georgia, United States, 30322
  • United States, Massachusetts
    • Massachusetts General Boston, Massachusetts, United States, 2114
  • United States, Michigan
    • Barbara Ann Karmanos Detroit, Michigan, United States, 48201
  • United States, New York
    • Roswell Park Buffalo, New York, United States, 14263
  • United States, Pennsylvania
    • Fox Chase Philadelphia, Pennsylvania, United States, 19111
  • United States, Tennessee
    • Vanderbilt Nashville, Tennessee, United States, 37232
  • United States, Texas
    • Mary Crowley Research Centers Dallas, Texas, United States, 75002
  • United States, Virginia
    • US Oncology Fairfax, Virginia, United States, 22031
  • Italy,
    • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.) S.r.l Meldola, , Italy, 47014
    • Istituto di Ricovero e Cura a Carattere Scientifico - Istituto Clinico Humanitas (Humanitas Research Milan, , Italy, 20089
    • Ospedale San Raffaele Milan, , Italy, 20132
    • Azienda Ospedaliero - Universitaria di Modena Policlinico Modena, , Italy, 41124
    • Azienda Ospedaliera Universitaria Senese - Policlinico Santa Maria Alle Scotte Siena, , Italy, 53100
  • Spain,
    • Hospital General Universitario Gregorio Maranon Madrid, , Spain, 28007
    • Hospital Universitario Ramon y Cajal Madrid, , Spain, 28034
    • Hospital Clinico Universitario Virgen de la Victoria Malaga, , Spain, 29010
    • Consejo Superior de Investigaciones Cientificas (CSIC) - Centro de Investigacion del Cancer (CIC) Salamanca, , Spain, 37007
    • Hospital Universitario La Fe Valencia, , Spain, 46009
    • Hospital Clinico Universitario de Valencia (CHUV) Valencia, , Spain, 46010
  • United Kingdom,
    • The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital - Northern Centre for Canc Newcastle upon Tyne, , United Kingdom, NE7 7DN
    • University Hospital Southampton NHS Foundation Trust - Southampton General Hospital Southampton, , United Kingdom, SO16 6YD

Sponsors and Collaborators

Millennium Pharmaceuticals, Inc.

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT02834247
Other Study ID Numbers: 2016-000853-10
Study First Received:
Last Updated:
Health Authority:

Additional relevant MeSH terms:

Carcinoma

Breast Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma, Squamous Cell

Triple Negative Breast Neoplasms

Nivolumab

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on August 15, 2019