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Trial record 2 of 2 for:    RO6895882

A Study of Intravenous (IV) Cergutuzumab Amunaleukin and Atezolizumab in Combination in Participants With Locally Advanced and/or Metastatic Solid Tumors

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ClinicalTrials.gov Identifier: NCT02350673
Recruitment Status : Recruiting
First Posted : January 30, 2015
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This is an open-label, multi-center, Phase Ib clinical study of cergutuzumab amunaleukin, in combination with atezolizumab, to investigate the safety, pharmacokinetics, and therapeutic activity in participants with locally advanced and/or metastatic carcinoembryonic antigen (CEA)-positive solid tumors, whose disease has progressed on or who are intolerant to the standard of care therapy. Enrolled participants who continue treatment will be treated until loss of clinical benefit, unacceptable toxicities, or withdrawal of consent. The study will include 2 parts: a dose-escalation Part I and a dose expansion Part II. The anticipated treatment period is 24 months for both cergutuzumab amunaleukin and atezolizumab and may be modified if emerging data suggest a benefit.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: Atezolizumab Drug: Cergutuzumab Amunaleukin Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b, Open-Label, Multi-Center, Dose Escalation Study of the Safety, Pharmacokinetics, and Therapeutic Activity of Cergutuzumab Amunaleukin, an Immunocytokine, Which Consists of a Variant of Interleukin 2 (IL 2v), That Targets Carcinoembryonic Antigen (CEA), and Atezolizumab, an Antibody That Targets Programmed Death-Ligand 1 (PD-L1), Administered Intravenously, in Patients With Locally Advanced and/or Metastatic Solid Tumors
Actual Study Start Date : June 29, 2015
Estimated Primary Completion Date : December 22, 2018
Estimated Study Completion Date : December 22, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cergutuzumab+Atezolizumab (Part I)
Participants will receive escalated IV doses of cergutuzumab amunaleukin in combination with atezolizumab. This is a Part I dose escalation phase of the study. Cergutuzumab amunaleukin will be escalated from a starting dose of 6 milligrams (mg) and dosing schedules of every week (qw) and every 2 weeks (q2w) may be explored. Atezolizumab will be administered in fixed flat doses of either 840 mg q2w or 1200 mg every 3 weeks (q3w). Treatment will be continued until loss of clinical benefit, unacceptable toxicities, or withdrawal of consent for a maximum treatment period of 24 months for both cergutuzumab amunaleukin and atezolizumab and may be modified if emerging data suggest longer treatment period is needed.
Drug: Atezolizumab
Participants will receive atezolizumab IV infusion at doses of 800 mg q2w or 1200 mg q3w.
Other Name: MPDL3280A, Tecentriq®

Drug: Cergutuzumab Amunaleukin
Participants will receive cergutuzumab amunaleukin IV infusion at escalated doses and at different dosing schedules in Part I and at MTD (or recommended dose) in Part II.
Other Name: RO6895882, CEA-IL2v

Experimental: Cergutuzumab +Atezolizumab (Part II)
This is a Part II expansion phase of the study. Participants will receive cergutuzumab amunaleukin at maximum tolerated dose (MTD) (or recommended dose) identified during Part I in combination with atezolizumab. Treatment will be continued until loss of clinical benefit, unacceptable toxicities, or withdrawal of consent for a maximum treatment period of 24 months for both cergutuzumab amunaleukin and atezolizumab and may be modified if emerging data suggest longer treatment period is needed.
Drug: Atezolizumab
Participants will receive atezolizumab IV infusion at doses of 800 mg q2w or 1200 mg q3w.
Other Name: MPDL3280A, Tecentriq®

Drug: Cergutuzumab Amunaleukin
Participants will receive cergutuzumab amunaleukin IV infusion at escalated doses and at different dosing schedules in Part I and at MTD (or recommended dose) in Part II.
Other Name: RO6895882, CEA-IL2v




Primary Outcome Measures :
  1. Number of Participants with Dose-Limiting Toxicities [ Time Frame: Day 1 up to Day 21 ]
  2. MTD of Cergutuzumab Amunaleukin [ Time Frame: Day 1 up to Day 21 ]
  3. Recommended Phase II Dose of Cergutuzumab Amunaleukin [ Time Frame: Day 1 up to Day 21 ]
  4. Percentage of Participants with Adverse Events [ Time Frame: Baseline up to 30 months ]
  5. Percentage of Participants with Infusion-Related Reactions [ Time Frame: Baseline up to 30 months ]
  6. Percentage of Participants with Seroconversion of Autoantibodies [ Time Frame: Screening up to 30 months (assessed at Screening, predose [Hour 0] on Day 1 of Cycles 2, 4, and 6, and every 3 months after Cycle 6 up to approximately 30 months [cycle length= 14 or 21 days]) ]
    Seroconversion is defined as the presence of at least one of the following autoantibodies: anti-nuclear antibody, antidouble-stranded deoxyribose nucleic acid (DNA), cytoplasmic anti-neutrophil cytoplasmic antibody, and perinuclear anti-neutrophil cytoplasmic antibody.

  7. Forced Expiratory Volume [ Time Frame: Screening (up to 28 days prior to Cycle 1 Day 1) ]
  8. Forced Vital Capacity [ Time Frame: Screening (up to 28 days prior to Cycle 1 Day 1) ]
  9. Percentage of Participants with Anti-Atezolizumab Antibodies [ Time Frame: Day 1 Cycle 1 up to 30 months (assessed at Day 1 of Cycles 1, 2, 3, 4, study completion/early discontinuation [up to 30 months], 28 and 120 days post last infusion up to approximately 30 months [cycle length = 14 or 21 days]) ]
  10. Percentage of Participants with Anti-Cergutuzumab Amunaleukin Antibodies [ Time Frame: Day 1 Cycle 1 up to 30 months (assessed at Day 1 of Cycles 1, 2, 3, 4, study completion/early discontinuation [up to 30 months], 28 and 120 days post last infusion up to approximately 30 months [cycle length = 14 or 21 days]) ]

Secondary Outcome Measures :
  1. Percentage of Participants with Objective Response of Complete Response (CR) or Partial Response (PR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 as Determined by the Investigator [ Time Frame: Screening up to disease progression or death due to any cause whichever occurs first (assessed at Weeks 8 and 12, every 8 weeks thereafter for the first year, and every 12 weeks thereafter up to approximately 30 months overall) ]
  2. Percentage of Participants with Disease Control (Tumor Response of CR or PR or Stable Disease [SD]) Based on RECIST v1.1 as Determined by the Investigator [ Time Frame: Screening up to disease progression or death due to any cause whichever occurs first (assessed at Weeks 8 and 12, every 8 weeks thereafter for the first year, and every 12 weeks thereafter up to approximately 30 months overall) ]
  3. Percentage of Participants with SD, Based on RECIST v1.1 as Determined by the Investigator [ Time Frame: Screening up to disease progression or death due to any cause whichever occurs first (assessed at Weeks 8 and 12, every 8 weeks thereafter for the first year, and every 12 weeks thereafter up to approximately 30 months overall) ]
  4. Progression-Free Survival Based on RECIST v1.1 as Determined by the Investigator [ Time Frame: Screening up to disease progression or death due to any cause whichever occurs first (assessed at Weeks 8 and 12, every 8 weeks thereafter for the first year, and every 12 weeks thereafter up to approximately 30 months overall) ]
  5. Overall Survival [ Time Frame: Screening up to death due to any cause (up to approximately 30 months overall) ]
  6. Area Under the Concentration Time Curve (AUC) of Cergutuzumab Amunaleukin in "Atezolizumab q2w and Cergutuzumab Amunaleukin q2w" [ Time Frame: Baseline up to 30 months (detailed timeframe is provided in the outcome description) ]
    Atezolizumab is presented as PDL and cergutuzumab amunaleukin as CergA. Pre-infusion (PrI) (Hour 0) of PDL (PDL infusion length=60 minutes [min]), mid of infusion of CergA (CergA infusion length=360 min), end of infusion (EoI), 2, 4, 24, 72, 120 hr after CergA EoI, 169.5 hr after PDL EoI on Day 1, Cycles 1 and 4; 2, 24 hr after CergA EoI on Day 1, Cycle 2; 2 hr after CergA EoI on Day 1, Cycle 3; mid of infusion of CergA, CergA EoI, and 2 hr after CergA EoI infusion on Day 1, Cycle 5; 2, 24, 120 hr after CergA EoI on Day 1, Cycle 6; mid of infusion of CergA, CergA EoI, 2 hr after EoI of CergA on Cycle 7 Day 1 and every cycle thereafter up to study completion/early termination (up to 30 months); 28, 120 days after last infusion (up to 30 months) (cycle length = 14 days)

  7. AUC of Cergutuzumab Amunaleukin in "Atezolizumab q3w and Cergutuzumab Amunaleukin qw" [ Time Frame: Baseline up to 30 months (detailed timeframe is provided in the outcome description) ]
    Atezolizumab is presented as PDL and cergutuzumab amunaleukin as CergA. PrI (Hour 0) of CergA (infusion length=360 min), mid of infusion of CergA, EoI, 1.5, 4, 24, 48, 72, 96 hr after CergA EoI on Day 1, Cycles 1, 2; mid of infusion of CergA, EoI, 1.5, 2, 4, 24, 48, 72, 96 hr after CergA EoI on Days 8 and 15, Cycle 1; 2, 24 hr after CergA EoI on Day 8, Cycle 2; 2 hr after CergA EoI on Day 1, Cycle 3; mid of infusion of CergA, EoI, 2 hr after CergA EoI on Day 15, Cycle 3; 2 hr after CergA EoI on Days 1, 8 Cycle 4; mid of infusion of CergA, EoI, 2 hr after EoI of CergA on Cycle 5 Day 1 and every cycle thereafter up to study completion/early discontinuation (up to 30 months); 28, 120 days after last infusion (up to 30 months) (cycle length = 21 days)

  8. Minimum Drug Concentration (Cmin) of Cergutuzumab Amunaleukin in "Atezolizumab q2w and Cergutuzumab Amunaleukin q2w" [ Time Frame: Baseline up to 30 months (detailed timeframe is provided in the outcome description) ]
    Atezolizumab is presented as PDL and cergutuzumab amunaleukin as CergA. PrI (Hour 0) of PDL (PDL infusion length=60 min), mid of infusion of CergA (CergA infusion length=360 min), EoI, 2, 4, 24, 72, 120 hr after CergA EoI, 169.5 hr after PDL EoI on Day 1, Cycles 1 and 4; 2, 24 hr after CergA EoI on Day 1, Cycle 2; 2 hr after CergA EoI on Day 1, Cycle 3; mid of infusion of CergA, CergA EoI, and 2 hr after CergA EoI infusion on Day 1, Cycle 5; 2, 24, 120 hr after CergA EoI on Day 1, Cycle 6; mid of infusion of CergA, CergA EoI, 2 hr after EoI of CergA on Cycle 7 Day 1 and every cycle thereafter up to study completion/early termination (up to 30 months); 28, 120 days after last infusion (up to 30 months) (cycle length = 14 days)

  9. Cmin of Cergutuzumab Amunaleukin in "Atezolizumab q3w and Cergutuzumab Amunaleukin qw" [ Time Frame: Baseline up to 30 months (detailed timeframe is provided in the outcome description) ]
    Atezolizumab is presented as PDL and cergutuzumab amunaleukin as CergA. PrI (Hour 0) of CergA (infusion length=360 min), mid of infusion of CergA, EoI, 1.5, 4, 24, 48, 72, 96 hr after CergA EoI on Day 1, Cycles 1, 2; mid of infusion of CergA, EoI, 1.5, 2, 4, 24, 48, 72, 96 hr after CergA EoI on Days 8 and 15, Cycle 1; 2, 24 hr after CergA EoI on Day 8, Cycle 2; 2 hr after CergA EoI on Day 1, Cycle 3; mid of infusion of CergA, EoI, 2 hr after CergA EoI on Day 15, Cycle 3; 2 hr after CergA EoI on Days 1, 8 Cycle 4; mid of infusion of CergA, EoI, 2 hr after EoI of CergA on Cycle 5 Day 1 and every cycle thereafter up to study completion/early discontinuation (up to 30 months); 28, 120 days after last infusion (up to 30 months) (cycle length = 21 days)

  10. Maximum Drug Concentration (Cmax) of Cergutuzumab Amunaleukin in "Atezolizumab q2w and Cergutuzumab Amunaleukin q2w" [ Time Frame: Baseline up to 30 months (detailed timeframe is provided in the outcome description) ]
    Atezolizumab is presented as PDL and cergutuzumab amunaleukin as CergA. PrI (Hour 0) of PDL (PDL infusion length=60 min), mid of infusion of CergA (CergA infusion length=360 min), EoI, 2, 4, 24, 72, 120 hr after CergA EoI, 169.5 hr after PDL EoI on Day 1, Cycles 1 and 4; 2, 24 hr after CergA EoI on Day 1, Cycle 2; 2 hr after CergA EoI on Day 1, Cycle 3; mid of infusion of CergA, CergA EoI, and 2 hr after CergA EoI infusion on Day 1, Cycle 5; 2, 24, 120 hr after CergA EoI on Day 1, Cycle 6; mid of infusion of CergA, CergA EoI, 2 hr after EoI of CergA on Cycle 7 Day 1 and every cycle thereafter up to study completion/early termination (up to 30 months); 28, 120 days after last infusion (up to 30 months) (cycle length = 14 days)

  11. Cmax of Cergutuzumab Amunaleukin in "Atezolizumab q3w and Cergutuzumab Amunaleukin qw" [ Time Frame: Baseline up to 30 months (detailed timeframe is provided in the outcome description) ]
    Atezolizumab is presented as PDL and cergutuzumab amunaleukin as CergA. PrI (Hour 0) of CergA (infusion length=360 min), mid of infusion of CergA, EoI, 1.5, 4, 24, 48, 72, 96 hr after CergA EoI on Day 1, Cycles 1, 2; mid of infusion of CergA, EoI, 1.5, 2, 4, 24, 48, 72, 96 hr after CergA EoI on Days 8 and 15, Cycle 1; 2, 24 hr after CergA EoI on Day 8, Cycle 2; 2 hr after CergA EoI on Day 1, Cycle 3; mid of infusion of CergA, EoI, 2 hr after CergA EoI on Day 15, Cycle 3; 2 hr after CergA EoI on Days 1, 8 Cycle 4; mid of infusion of CergA, EoI, 2 hr after EoI of CergA on Cycle 5 Day 1 and every cycle thereafter up to study completion/early discontinuation (up to 30 months); 28, 120 days after last infusion (up to 30 months) (cycle length = 21 days)

  12. Cmin of Atezolizumab in "Atezolizumab q2w and Cergutuzumab Amunaleukin q2w" [ Time Frame: Baseline up to 30 months (detailed timeframe is provided in the outcome description) ]
    Atezolizumab is presented as PDL and cergutuzumab amunaleukin as CergA. PrI (Hour 0) of PDL (PDL infusion length=60 min), mid of infusion of PDL, 0.5, 25.5, 121.5, 169.5, 313.5 hr after EoI of PDL on Day 1, Cycle 1; PrI (Hour 0), mid of infusion, 0.5 and 169.5 hr after PDL EoI on Day 1, Cycle 2; PrI (Hour 0) of PDL on Day 1, Cycle 3; PrI (Hour 0) of PDL, mid of infusion, 0.5, 25.5, 121.5, 169.5, 313.5 hr after PDL EoI on Day 1, Cycles 4, 6; study completion/early termination (up to 30 months), 28 and 120 days after last infusion (up to 30 months) (cycle length = 14 days)

  13. Cmin of Atezolizumab in"Atezolizumab q3w and Cergutuzumab Amunaleukin qw" [ Time Frame: Baseline up to 30 months (detailed timeframe is provided in the outcome description) ]
    Atezolizumab is presented as PDL and cergutuzumab amunaleukin as CergA. PrI (Hour 0) of PDL (PDL infusion length=60 min), mid of infusion of PDL, 0.5, 25.5, 121.5, 169.5 hr after PDL EoI on Day 1, Cycle 1, PrI (Hour 0) of CergA, 72 hr after CergA EoI on Day 15, Cycle 1; PrI (Hour 0) of PDL, mid of infusion of PDL, 0.5, 25.5, 169.5 hr after PDL EoI on Day 1, Cycle 2; 24 hr after CergA administration on Day 9, Cycle 2; PrI (Hour 0) of CergA on Day 15, Cycle 2; PrI (Hour 0) of PDL, 72 hr after CergA EoI, 169.5 hr after PDL EoI on Day 1, Cycle 3, PrI (Hour 0) of PDL on Day 15, Cycle 3; PrI (Hour 0) of PDL, mid of infusion of PDL, 0.5, 169.5 hr after PDL EoI on Day 1, Cycle 4; study completion/early termination (up to 30 months), 28 and 120 days after last infusion (up to 30 months) (cycle length = 21 days)

  14. Cmax of Atezolizumab in "Atezolizumab q2w and Cergutuzumab Amunaleukin q2w" [ Time Frame: Baseline up to 30 months (detailed timeframe is provided in the outcome description) ]
    Atezolizumab is presented as PDL and cergutuzumab amunaleukin as CergA. PrI (Hour 0) of PDL (PDL infusion length=60 min), mid of infusion of PDL, 0.5, 25.5, 121.5, 169.5, 313.5 hr after EoI of PDL on Day 1, Cycle 1; PrI (Hour 0), mid of infusion, 0.5 and 169.5 hr after PDL EoI on Day 1, Cycle 2; PrI (Hour 0) of PDL on Day 1, Cycle 3; PrI (Hour 0) of PDL, mid of infusion, 0.5, 25.5, 121.5, 169.5, 313.5 hr after PDL EoI on Day 1, Cycles 4, 6; study completion/early termination (up to 30 months), 28 and 120 days after last infusion (up to 30 months) (cycle length = 14 days)

  15. Cmax of Atezolizumab in "Atezolizumab q3w and Cergutuzumab Amunaleukin qw" [ Time Frame: Baseline up to 30 months (detailed timeframe is provided in the outcome description) ]
    Atezolizumab is presented as PDL and cergutuzumab amunaleukin as CergA. PrI (Hour 0) of PDL (PDL infusion length=60 min), mid of infusion of PDL, 0.5, 25.5, 121.5, 169.5 hr after PDL EoI on Day 1, Cycle 1, PrI (Hour 0) of CergA, 72 hr after CergA EoI on Day 15, Cycle 1; PrI (Hour 0) of PDL, mid of infusion of PDL, 0.5, 25.5, 169.5 hr after PDL EoI on Day 1, Cycle 2; 24 hr after CergA administration on Day 9, Cycle 2; PrI (Hour 0) of CergA on Day 15, Cycle 2; PrI (Hour 0) of PDL, 72 hr after CergA EoI, 169.5 hr after PDL EoI on Day 1, Cycle 3, PrI (Hour 0) of PDL on Day 15, Cycle 3; PrI (Hour 0) of PDL, mid of infusion of PDL, 0.5, 169.5 hr after PDL EoI on Day 1, Cycle 4; study completion/early termination (up to 30 months), 28 and 120 days after last infusion (up to 30 months) (cycle length = 21 days)

  16. Change from Baseline in Cluster of Differentiation (CD) 4 Positive (+) Type of Lymphocytes [ Time Frame: From Baseline to 30 months ]
  17. Change from Baseline in CD8+ Type of Lymphocytes [ Time Frame: From Baseline to 30 months ]
  18. Change from Baseline in Natural Killer Cells [ Time Frame: From Baseline to 30 months ]
  19. Change from Baseline in Monocytes [ Time Frame: From Baseline to 30 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Confirmed locally advanced and/or metastatic solid tumor, with at least one tumor lesion of non-critical location accessible to biopsy (with exception of non-small cell lung cancer [NSCLC] participants), and with confirmed progression at baseline that has progressed on, or participant is intolerant to, the standard of care therapy
  • Radiologically measurable and clinically evaluable disease as per RECIST v1.1
  • Life expectancy, in the opinion of the investigator, greater than or equal to (>=) 12 weeks
  • Eastern Cooperative Oncology Group Performance Status 0-1
  • All acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedure must have resolved to Grade less than or equal to (<=) 1, except alopecia (any grade) and Grade 2 peripheral neuropathy
  • Adequate cardiac, hematological, liver and renal function
  • Negative serum pregnancy test within 7 days prior to study treatment in premenopausal women and women <= 2 years after menopause
  • For women who are not postmenopausal and have not undergone surgical sterilization: agreement to remain abstinent or use two adequate non-hormonal methods of contraception including at least one method with a failure rate of <1% per year during the treatment period and for at least five months after the last dose of atezolizumab and at least four months after the last dose of cergutuzumab amunaleukin, whichever is the longest
  • For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm
  • Locally or centrally confirmed CEA expression in archival tumor tissue
  • Participants with unilateral pleural effusion will be eligible for inclusion if they fulfill the Global Initiative for Obstructive Lung Disease classification of 0-1 level for pulmonary function and New York Heart Association (NYHA) classification class 1 for cardiac function

Exclusion Criteria:

  • Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging evaluation during screening and prior radiographic assessments; participants with a history of treated asymptomatic CNS metastases are eligible
  • Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for >= 2 weeks prior to randomization
  • Leptomeningeal disease
  • Participants with an active second malignancy (other than non-melanoma skin cancer or cervical carcinoma in situ). Participants who have a history of malignancy are not considered to have an active malignancy if they have completed therapy and are considered by their treating physician to be at <= 30 percent (%) risk for relapse
  • Evidence of significant, uncontrolled concomitant diseases which could affect compliance with the protocol or interpretation of results, including diabetes mellitus, history of relevant pulmonary disorders, and known autoimmune diseases
  • Participants with bilateral pleural effusion and NSCLC participants with uni- or bilateral effusion confirmed at screening by X-ray are not eligible
  • Uncontrolled hypertension, unstable angina, congestive heart failure of any NYHA classification stage greater than (>) 2, serious cardiac arrhythmia requiring treatment (exceptions: atrial fibrillation, paroxysmal supraventricular tachycardia), history of myocardial infarction within 6 months of enrollment
  • Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1 or anticipation that such a live attenuated vaccine will be required during the study. Influenza vaccination should be given during influenza season only. Participants must not receive live, attenuated influenza vaccine within 4 weeks prior to Cycle 1, Day 1, at any time during the study or 5 months after the last dose of atezolizumab
  • Known Human Immunodeficiency Virus (HIV)
  • Active hepatitis B (HBV) or hepatitis C (HCV) infection
  • Severe infections within 4 weeks prior to Cycle 1, Day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
  • Received oral or intravenous (IV) antibiotics within 2 weeks prior to Cycle 1, Day 1. Participants receiving prophylactic antibiotics (for prevention of a urinary tract infection chronic obstructive pulmonary disease) are eligible
  • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug
  • Major surgery or significant traumatic injury less than (<) 28 days prior to the first cergutuzumab amunaleukin infusion (excluding biopsies) or anticipation of the need for major surgery during study treatment
  • Dementia or altered mental status that would prohibit informed consent
  • History or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Bell's palsy, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis
  • Participants with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone or participants with controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible for this study with approval by the medical monitor
  • Inclusion of participants with confirmed positive serology of at least one auto-antibody panel (anti-nuclear antibody, anti-double stranded DNA, cytoplasmic anti-neutrophil cytoplasmic antibody, and perinuclear anti-neutrophil cytoplasmic antibody) at screening should be discussed between Sponsor and investigators, and if judged clinically relevant could be referred to a specialist (Rheumatologist) to exclude an underlying auto-immune disease
  • History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
  • Baseline QTc interval > 470 milliseconds (ms), baseline resting bradycardia <45 beats per minute (bpm), or baseline resting tachycardia >100 bpm
  • Pregnant or breast-feeding women
  • Known hypersensitivity to any of the components of cergutuzumab amunaleukin and atezolizumab; hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
  • Investigational therapy within 28 days prior to initiation of study treatment
  • Any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3 weeks prior to initiation of study treatment, with the exceptions stated in the protocol
  • Prior corticosteroids as anti-cancer therapy within a minimum of 14 days of first receipt of study drug
  • Last dose with any of the following agents including but not limited to: etanercept, infliximab, tacrolimus, cyclosporine, mycophenolic acid, alefacept, or efalizumab <28 days prior to first dose of study drug
  • Last dose of prior immunotherapies including but not limited to: interferon alpha, interferon-beta, interleukin (IL)-2, conjugated IL-2, cergutuzumab amunaleukin (CEA-IL2v) , cytokines, anti-cytotoxic T lymphocyte antigen-4, anti-PD-L1, or anti-PD-1 <28 days prior to first cergutuzumab amunaleukin infusion
  • History of severe immune-related adverse effects from CEA-IL2v or anti-PD-1 (nivolumab, pembrolizumab) or anti-PD-L1 (atezolizumab) therapies (Common Terminology Criteria for Adverse Events Grade 3 and 4)
  • Regular immunosuppressive therapy
  • Treatment with systemic immunosuppressive medications including, but not limited to: prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents within 2 weeks prior to Cycle 1, Day 1. Participants who have received acute and/or low-dose systemic immunosuppressant medications may be enrolled in the study after discussion with and approval by the Medical Monitor. The use of inhaled corticosteroids and mineralocorticoids for participants with orthostatic hypotension or adrenocortical insufficiency is allowed
  • Radiotherapy within the last 4 weeks before start of study drug treatment with the exception of limited field palliative radiotherapy for bone pain relief

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): NCT02350673


Contacts
Contact: Reference Study ID Number: BP29435 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

Locations
United States, Connecticut
Yale Cancer Center; Medical Oncology Active, not recruiting
New Haven, Connecticut, United States, 06520
United States, New York
Columbia Univ Med Ctr Active, not recruiting
New York, New York, United States, 10032
Memorial Sloan Kettering Cancer Center Completed
New York, New York, United States, 10065
United States, Tennessee
SCRI-Tennessee Oncology Active, not recruiting
Nashville, Tennessee, United States, 37203
Canada, Ontario
University Health Network; Princess Margaret Hospital; Medical Oncology Dept Recruiting
Toronto, Ontario, Canada, M5G 2M9
Denmark
Herlev Hospital; Onkologisk afdeling Active, not recruiting
Herlev, Denmark, 2730
Rigshospitalet; Onkologisk Klinik Active, not recruiting
København Ø, Denmark, 2100
Netherlands
Antoni van Leeuwenhoek Ziekenhuis Completed
Amsterdam, Netherlands, 1066 CX
Erasmus MC Active, not recruiting
Rotterdam, Netherlands, 3015 GD
Spain
Clinica Universitaria de Navarra; Servicio de oncología Recruiting
Pamplona, Navarra, Spain, 31008
Hospital Univ Vall d'Hebron; Servicio de Oncologia Active, not recruiting
Barcelona, Spain, 08035
START Madrid. Centro Integral Oncologico Clara Campal; CIOCC Completed
Madrid, Spain, 28050
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia Completed
Valencia, Spain, 46010
Switzerland
CHUV; Departement d'Oncologie Recruiting
Lausanne, Switzerland, 1011
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02350673     History of Changes
Other Study ID Numbers: BP29435
2014-000948-14 ( EudraCT Number )
First Posted: January 30, 2015    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
Atezolizumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs