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Solid TumorPhase 1NCT02715531

A Study of the Safety and Efficacy of Atezolizumab Administered in Combination With Bevacizumab and/or Other Treatments in Participants With Solid Tumors

A Phase 1 study testing 5-FU, Atezolizumab and Bevacizumab in people with Solid Tumor, run by Hoffmann-La Roche at 30 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will evaluate the safety, efficacy, and pharmacokinetics of atezolizumab in combination with bevacizumab, bevacizumab + oxaliplatin, leucovorin and 5-fluorouracil (5-FU) (FOLFOX), vanucizumab, nab-paclitaxel + gemcitabine, FOLFOX, or 5-FU + cisplatin, in participants with solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor
What is being tested?
5-FU, Atezolizumab and Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
243 participants
Where
30 sitesin 7 countries
Study dates
6 Apr 2016to 31 May 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • General Inclusion criteria
  • Measurable disease per RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate hematologic and end organ function
  • Resolution of any acute, clinically significant treatment-related toxicity from prior therapy to Grade less than or equal to (</=) 1 prior to study entry, with the exception of alopecia
  • Ready to use reliable contraceptive procedures
Show all 36Show fewer
  • Participants with advanced or metastatic and/or unresectable HCC
  • The participant has disease that is not amenable to a curative approach
  • No prior line of systemic therapy (includes participants who are sorafenib-naïve)
  • Willing to undergo fresh liver biopsy if provided archival tissue was taken greater than (>) 6 months from Cycle 1 Day 1
  • Child-Pugh Score of up to B7
  • Serum bilirubin </= 3 times upper limit of normal (x ULN)
  • International normalized ratio (INR) and activated partial thromboplastin time (aPTT) </= 2 x ULN
  • Albumin >2.8 grams per deciliter (g/dL)
  • Documented virology status of hepatitis, as confirmed by screening hepatitis B surface antigen (HBsAg), antibody to hepatitis B core antigen (anti-HBc), and/or anti-hepatitis C virus (anti-HCV)
  • Antiviral therapy per local standard-of-care if active hepatitis B virus (HBV)
  • Inclusion Criteria Specific to Arm A (Patients must also meet all of the following specific inclusion criteria to be eligible for enrollment in Arm A:)
  • Child-Pugh score of up to B7
  • Willing to undergo biopsy if archival tissue is not available or if archival tissue was taken >6 months from Cycle 1, Day 1
  • Anti-viral therapy per local standard-of-care if active hepatitis B virus (HBV).
  • Inclusion Criteria Specific to Arm F (Patients must also meet all of the following specific inclusion criteria to be eligible for enrollment in Arm F:)
  • LIfe expectancy >=3 months, as determined by the investigator
  • Child-Pugh score A
  • Platelet count ≥ 75x109/L (75,000/uL) without transfusion
  • Availability at the site of tumor specimens in paraffin blocks (preferred) or 16 unstained slides, with an associated pathology report, prior to study entry
  • Anti-viral therapy per local standard-of-care if active hepatitis B virus (HBV).
  • Inclusion Criteria Specific to Gastric Cancer (Arm B) (Patients must also meet all of the following specific inclusion criteria to be eligible for enrollment in Arm B:)
  • Histologically or cytologically confirmed locally advanced or metastatic adenocarcinoma of the stomach or GEJ in participants who have not received prior systemic therapy for metastatic disease
  • Absence of HER2 expression documented as in situ hybridization (ISH) negative on previously collected and assessed tumor tissue upon initial diagnosis of disease
  • Inclusion criteria specific to metastatic pancreatic cancer (Arm C) (Patients must also meet all of the following specific inclusion criteria to be eligible for enrollment in Arm C:)
  • Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas
  • No previous radiotherapy, surgery, chemotherapy, or investigational therapy for the treatment of metastatic disease
  • Inclusion Criteria Specific to mEC (Arm E) (Patients must also meet all of the following specific inclusion criteria to be eligible for enrollment in Arm E:)
  • Histologically or cytologically confirmed locally mEC or metastatic adenocarcinoma of the GEJ Siewert Classification Type I in participants who have not received prior systemic therapy for primary and metastatic disease or chemoradiation therapy for primary disease
  • Absence of HER2 expression documented as ISH-negative on previously collected and assessed tumor tissue upon initial diagnosis of disease
  • Willing to undergo biopsy if archival tissue is not available or if archival tissue was taken >6 months from Cycle 1 Day 1

Who cannot join

  • General Exclusion Criteria
  • Uncontrolled pleural effusion, pericardial effusion, or ascites
  • Uncontrolled tumor-related pain
  • Uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy
  • Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, fatty liver, and inherited liver disease (exception for participants in Arm A and Arm F)
  • Known primary central nervous system (CNS) malignancy or untreated or active CNS metastases
Show all 53Show fewer
  • Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or other recombinant human antibodies
  • Positive test for Human Immunodeficiency Virus (HIV)
  • Active hepatitis B (chronic or acute), or hepatitis C (exception for participants in Arm A and Arm F)
  • Active tuberculosis
  • Severe infections within 4 weeks prior to Day 1
  • Signs or symptoms of significant infection within 2 weeks prior to Day 1
  • Received oral or IV antibiotics within 2 weeks prior to Cycle 1 Day 1
  • Significant cardiovascular disease, such as New York Heart Association (NYHA) cardiac disease (Class II or greater), myocardial infarction within 3 months prior to Day 1, unstable arrhythmias, or unstable angina
  • History of stroke, reversible ischemic neurological defect or transient ischemic attack within 6 months prior to Day 1
  • 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
  • Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's and/or Medical Monitor's judgment, precludes the participants safe participation in and completion of the study
  • Malignancies other than pancreatic carcinoma within 2 years prior to study start, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent)
  • Prior treatment with anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA4), anti-programmed death-1 (anti-PD-1), or anti-programmed death ligand-1 (anti-PD-L1) therapeutic antibody
  • Treatment with systemic immunostimulatory agents within 6 weeks or five half-lives of the drug, whichever is longer, prior to screening
  • Treatment with systemic corticosteroids or other immunosuppressive medications within 2 weeks prior to Cycle 1, Day 1
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
  • Participants with prior allogeneic bone marrow transplantation or prior solid organ transplantation
  • Known allergies to oxaliplatin (or other platinum agents), leucovorin, 5-FU, nab-paclitaxel (or other taxanes) or gemcitabine
  • Exclusion Criteria Specific to Bevacizumab-Containign Arms (Arms A, B, and F) (Patients who meet any of the following criteria will be excluded from enrollment into bevacizumab-containing Arms A, B, and F:)
  • Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 3 days prior to the first dose of bevacizumab or vanucizumab
  • History of abdominal or tracheoesophageal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within 6 months prior to Day 1
  • History of intestinal obstruction and/or clinical signs or symptoms of GI obstruction within 6 months prior to Day 1 of Cycle 1
  • Clinical signs or symptoms of GI obstruction or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding
  • Evidence of abdominal free air that is not explained by paracentesis or recent surgical procedure
  • Serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture
  • Proteinuria, as demonstrated by urine dipstick or > 1.0 g of protein in a 24-hour urine collection
  • Metastatic disease that involves major airways or blood vessels, or centrally located mediastinal tumor masses of large volume. HCC participants (Arm A and F) with vascular invasion of the portal or hepatic veins may be enrolled
  • History of intra-abdominal inflammatory process within 6 months prior to Day 1 of Cycle 1
  • Radiotherapy within 28 days and abdominal/pelvic radiotherapy within 60 days prior to Day 1 of Cycle 1
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 of Cycle 1
  • Chronic daily treatment with a nonsteroidal anti-inflammatory drug (NSAID)
  • Exclusions specific to Arms A and F (HCC) (Patients who meet any of the following specific exclusion criteria will be excluded from enrollment in Arms A and F:)
  • Participants with untreated or incompletely treated varices with bleeding or high-risk for bleeding
  • Treatment with any HCV anti-viral therapy within 4 weeks prior to Cycle 1 Day 1
  • Moderate or severe ascites
  • Hepatic encephalopathy
  • Exclusion Criteria Specific to Arm B (Gastric Cancer) (Patients who meet any of the following specific exclusion criteria will be excluded from enrollment in Arm B:)
  • HER2 expression as defined by ISH positive and/or 3+ by immunohistochemistry (IHC)
  • Prior treatment with an oxaliplatin-containing regimen
  • Previous antiangiogenic therapy
  • Ongoing treatment for epilepsy
  • Exclusion Criteria Specific to Arm C (Metastatic Pancreatic Cancer) (Patients who meet any of the following specific exclusion criteria will be excluded from enrollment in Arm C:)
  • Patients with only locally advanced disease
  • Presence of islet cell neoplasms
  • Exclusions Specific to Arm E (Metastatic Esophageal Cancer) (Patients who meet any of the following specific exclusion criteria will be excluded from enrollment in Arm E:)
  • HER2 expression as defined by ISH positive and/or 3+ by immunohistochemistry
  • Prior chemotherapy treatment, including radio-sensitization in pre- and post-operative settings

Trial locations and contacts

30 sites in 7 countries.

30 sites in 7 countries

United States12 sites

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27514

  • Duke Cancer Institute

    Durham, North Carolina, 27710

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Sarah Cannon Research Inst.

    Nashville, Tennessee, 37203

  • Yale School of Medicine

    New Haven, Connecticut, 06510

  • Columbia University Medical Center

    New York, New York, 10027

  • Stanford Cancer Institute; Hematology

    Palo Alto, California, 94305

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

Other trials in United States

South Korea5 sites

  • Seoul National University Bundang Hospital

    Seongnam-si, 13605

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06531

Other trials in South Korea

Taiwan5 sites

  • China Medical University Hospital

    North Dist., 40402

  • National Cheng Kung University Hospital

    Tainan, 70457

  • National Taiwan University Hospital

    Taipei, 10002

  • Taipei Veterans General Hospital

    Taipei, 112

  • Chang Gung Medical Foundation - LINKOU; Dept of Cardiology

    Taoyuan County, 00333

Other trials in Taiwan

Japan4 sites

  • National Cancer Center Hospital East

    Chiba, 277-8577

  • Yokohama City University Medical Center

    Kanagawa, 232-0024

  • Kanagawa Cancer Center

    Kanagawa, 241-8515

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135-8550

Other trials in Japan

Australia2 sites

  • Monash Medical Centre Clayton

    Clayton, Victoria, 3168

  • Austin Hospital

    Heidelberg, Victoria, 3084

Other trials in Australia

China1 site

  • The 81st Hospital of P.L.A.

    Nanjing, 210002

Other trials in China

New Zealand1 site

  • Auckland City Hospital

    Auckland, 1023

Other trials in New Zealand

About this study

Official title: An Open-Label, Multicenter Phase Ib Study of The Safety and Efficacy of Atezolizumab (Anti-PD-L1 Antibody) Administered in Combination With Bevacizumab and/or Other Treatments in Patients With Solid Tumors

This study will evaluate the safety, efficacy, and pharmacokinetics of atezolizumab in combination with bevacizumab, bevacizumab + oxaliplatin, leucovorin and 5-fluorouracil (5-FU) (FOLFOX), vanucizumab, nab-paclitaxel + gemcitabine, FOLFOX, or 5-FU + cisplatin, in participants with solid tumors.

Conditions
Solid Tumor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 5-FUDrug

    5-FU (400 mg/m^2) will be administered as an IV bolus, followed by 2400 mg/m^2 by continuous IV infusion over 46 (± 1) hours, q2w.

  • AtezolizumabDrug

    Also called Tecentriq; RO5541267

    Participants will receive atezolizumab in a flat dose of 1200 mg q3w (Arm A, Group E2, and Arm F) or 840 mg q2w (Arm B, Arm C, and Groups E1 and E3).

  • BevacizumabDrug

    Participants will receive bevacizumab at 15 mg/kg q3w (Arm A and Group F1) or 10 mg/kg q2w (Arm B).

  • GemcitabineDrug

    Gemcitabine will be administered according to the local prescribing information. The starting dose-level of gemcitabine (1000 mg/m^2) will be administered intravenously over 35 (± 5) minutes on Days 1, 8, and 15 of each 28-day cycle (3-weeks-on/1-week-off schedule).

  • LeucovorinDrug

    Leucovorin 200 mg/m^2 L-isomer form or 400 mg/m^2 D,L-racemic form will be administered IV over 120 (± 15) minutes, q2w.

  • Nab-PaclitaxelDrug

    Nab-Paclitaxel will be administered according to the local prescribing information. The starting dose-level of nab-paclitaxel (125 mg/m^2) will be administered intravenously over 35 (± 5) minutes on Days 1, 8, and 15 of each 28-day cycle (3-weeks-on/1-week-off schedule).

  • OxaliplatinDrug

    Oxaliplatin 85 mg/m^2 will be administered IV over 120 (± 5) minutes q2w.

  • CapecitabineDrug

    Capecitabine may be administered after 6 months at the discretion of the investigator (range of 650-1000 mg/m^2) twice daily on Days 1-4 of a 21-day cycle.

  • CisplatinDrug

    Cisplatin will be administered as 80 mg/m^2 IV over 120 minutes q3w (Group E2).

Study groups in NCT02715531
Study groupRoleWhat they receive
Arm A (Hepatocellular Carcinoma [HCC], All subtypes)ExperimentalParticipants with advanced or metastatic and/or unresectable HCC who have received no prior treatment are non-randomized and will receive atezolizumab and bevacizumab, every 3 weeks (q3w), each cycle of 21 days, as long as participants are experiencing clinical benefit in the opinion of the investigator.
Receives: Drug: Atezolizumab; Drug: Bevacizumab
Arm B (Gastric Cancer)ExperimentalParticipants with previously untreated human epidermal growth factor receptor 2 (HER2)-negative adenocarcinoma of the stomach or gastroesophageal junction (GEJ) are non-randomized and will receive atezolizumab, bevacizumab, and FOLFOX (oxaliplatin, leucovorin, and 5-fluorouracil [FU]), every 2 weeks (q2w), each cycle of 28 days, as long as participants are experiencing clinical benefit in the opinion of the investigator. Oxaliplatin will be administered for up to 8 cycles. After 6 months, at discretion of investigator, capecitabine may be administered as maintenance therapy without oxaliplatin instead of infusional 5-FU and leucovorin, and biologic therapy may be given every 3 weeks (q3w). In the event that a patient experiences unacceptable toxicity after replacement of infusional 5-FU and leucovorin with capecitabine, the patient may be allowed to switch back to 5-FU and leucovorin following investigator discussion with the Medical Monitor.
Receives: Drug: 5-FU; Drug: Atezolizumab; Drug: Bevacizumab; Drug: Leucovorin; Drug: Oxaliplatin; Drug: Capecitabine
Arm C (Metastatic Pancreatic Cancer)ExperimentalParticipants with previously untreated metastatic pancreatic cancer are non-randomized and will receive atezolizumab q2w starting on Day 1, Cycle 1 (each cycle of 28 days). Administration of nab-paclitaxel followed by gemcitabine will occur on Days 1, 8, and 15 of each cycle (3-weeks-on/1-week-off schedule). Treatment consisting of atezolizumab with gemcitabine and nab-paclitaxel may be continued as long as participants are experiencing clinical benefit in the opinion of the investigator.
Receives: Drug: Atezolizumab; Drug: Gemcitabine; Drug: Nab-Paclitaxel
Arm E (Randomized Metastatic Esophageal Cancer)ExperimentalParticipants with squamous metastatic esophageal cancer (mEC) will be randomized (1:1) into Group E1 and Group E2. All participants with metastatic adenocarcinoma of esophageal carcinoma or GEJ Siewert Classification Type I will be enrolled into Group E3. In Groups E1 and E3, participants will receive atezolizumab and FOLFOX, q2w, each cycle of 28 days, as long as participants are experiencing clinical benefit in opinion of the investigator. Oxaliplatin will be administered for up to 8 cycles. In Group E2, participants will receive atezolizumab followed by cisplatin and 5-FU q3w. Cisplatin will be administered for up to 6 cycles. Treatment with atezolizumab in combination with 5-FU may be continued as long as participants experience clinical benefit in opinion of the investigator.
Receives: Drug: 5-FU; Drug: Atezolizumab; Drug: Leucovorin; Drug: Oxaliplatin; Drug: Cisplatin
Arm F (Randomized HCC)ExperimentalParticipants with advanced or metastatic and/or unresectable HCC who have received no prior systemic treatment will be randomized (1:1) into Group F1 and Group F2. Participants will receive atezolizumab alone (Group F2) or combined with bevacizumab (Group F1) on a q3w schedule, with dosing on Day 1 of each 21 day Cycle. Treatment with atezolizumab with or without bevacizumab may be continued as long as participants are experiencing clinical benefit in the opinion of the investigator. Participants who are randomly assigned to Group F2 (atezolizumab monotherapy) and experience investigator-assessed unequivocal radiographic progression as per RECIST v1.1 will also be given the option to cross over to atezolizumab and bevacizumab combination therapy, provided they meet the criteria for crossover and Medical Monitor approval is obtained.
Receives: Drug: Atezolizumab; Drug: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With At Least One Adverse Event, with Severity Determined According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)

    Measured: From screening to up to 90 days after the last dose of study drug (up to approximately 55 months)

  2. Percentage of Participants with Objective Response as Determined By The Independent Review Facility (IRF) According To Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (Arm A)

    Measured: From screening to end of study (approximately 55 months)

  3. Progression-Free Survival (PFS) as determined by the Independent Review Facility (IRF) according to RECIST v 1.1 (Arm F)

    Measured: From randomization to the first occurrence of disease progression or death from any cause (whichever occurs first)

Secondary outcomes (21)

  1. Serum Concentrations of Atezolizumab (All Arms)

    Measured: Predose (0 hour[h]), 30 minutes(min) postdose on Day 1 of Cycles(Cy) 1 and 3; Predose(0h) on Day 1 of Cy 2,4,8 and every 8 Cy until treatment discontinuation (up to 55 months); 120 days after last dose (Cy length=21-28 days; up to 55 months)

  2. Serum Concentrations of Bevacizumab (Arm A, Arm B and Group F1)

    Measured: Predose (0 h) and 30 min postdose (infusion length=30-90 min) on Day 1 of Cy 1 and 3; at treatment discontinuation (up to 55 months); at 120 days after last dose (Cy length=21-28 days; up to 55 months)

  3. Plasma Concentration of Oxaliplatin (Arm B and Group E1)

    Measured: Predose (0 h) and 5-10 min before the end of infusion (infusion length=120 min) on Day 1 of Cycles 1 and 3 (Cycle length=21-28 days; up to approximately 3 months)

  4. Plasma Concentration of 5-FU (Arm B and Arm E)

    Measured: Predose (0 h), immediately following bolus administration and 2 hours post-bolus dose on Day 1 of Cycles 1 and 3 (Cycle length=21-28 days; up to approximately 3 months)

  5. Plasma Concentration of Cisplatin (Group E2)

    Measured: Predose (0 h) and 5-10 minutes before the end of infusion (infusion length=120 min) on Day 1 of Cycles 1 and 3 (Cycle length=21 days; up to approximately 3 months)

  6. Plasma Concentration of nab-Paclitaxel (Arm C)

    Measured: Predose (0 h), 5-10 minutes before the end of infusion and 1 hour after the end of the infusion (infusion length=35 min) on Day 1 of Cycles 1 and 3 (Cycle length=28 days; up to approximately 3 months)

  7. Plasma Concentration of Gemcitabine (Arm C)

    Measured: Predose (0 h), 5-10 minutes before the end of infusion and 1 hour after the end of the infusion (infusion length=35 min) on Day 1 of Cycles 1 and 3 (Cycle length=28 days) (up to approximately 3 months)

  8. Percentage of Participants with Objective Response as Determined by the IRF according to RECIST v 1.1 (Arm F)

    Measured: Baseline, every 8 weeks (± 1 week) for the first 12 months following Cycle 1 Day 1, and every 12 weeks (± 1 week) thereafter up to study completion (Cycle length=21-28 days; up to approximately 55 months)

  9. Percentage of Participants with Objective Response as Determined By The Investigator According To RECIST v 1.1 (Arm A and Arm F)

    Measured: Baseline, every 8 weeks (± 1 week) for the first 12 months following Cycle 1 Day 1, and every 12 weeks (± 1 week) thereafter up to study completion (Cycle length=21-28 days; up to approximately 55 months)

  10. Percentage of Participants with Objective Response as Determined by the IRF according to HCC-Specific Modified RECIST (mRECIST) (Arm A and Arm F)

    Measured: Baseline, every 8 weeks (± 1 week) for the first 12 months following Cycle 1 Day 1, and every 12 weeks (± 1 week) thereafter up to study completion (Cycle length=21-28 days; up to approximately 55 months)

  11. Duration of Objective Response as Determined by the IRF according to RECIST v1.1 (Arm A and Arm F)

    Measured: From the first occurrence of a documented objective response to disease progression or death from any cause, whichever comes first (up to approximately 55 months)

  12. Duration of Objective Response as Determined by The Investigator According to RECIST v 1.1 (Arm A and Arm F)

    Measured: From the first occurrence of a documented objective response to disease progression or death from any cause, whichever comes first (up to approximately 55 months)

  13. Duration of Objective Response as Determined by the IRF According to HCC-Specific mRECIST (Arm A and Arm F)

    Measured: From the first occurrence of a documented objective response to disease progression or death from any cause, whichever comes first (up to approximately 55 months)

  14. PFS Duration as Determined by The IRF According to RECIST v1.1 (Arm A)

    Measured: From the first dose of study treatment to the first occurrence of disease progression or death from any cause, whichever comes first (up to approximately 55 months)

  15. PFS Duration as Determined by the Investigator According To RECIST v 1.1 (Arm A and Arm F)

    Measured: From the first dose of study treatment (Arm A) or randomization (Arm F) to the first occurrence of disease progression or death from any cause, whichever comes first (up to approximately 55 months)

  16. PFS Duration as Determined by the IRF Acording to HCC-Specific mRECIST (Arm A and Arm F)

    Measured: From the first dose of study treatment (Arm A) or randomization (Arm F) to the first occurrence of disease progression or death from any cause, whichever comes first (up to approximately 55 months)

  17. Overall Survival (OS) Duration (Arm A and Arm F)

    Measured: Baseline up to study completion or death, whichever occurs first (up to approximately 55 months)

  18. Time to Radiological Progression (TTRP) as Determined by the IRF According to RECIST v1.1 (Arm A and Arm F)

    Measured: From the first dose of study treatment (Arm A) or randomization (Arm F) to the first occurrence of radiographic disease progression (up to approximately 55 months)

  19. TTRP as Determined by The Investigator According to RECIST (Arm A and Arm F)

    Measured: From the first dose of study treatment (Arm A) or randomization (Arm F) to the first occurrence of radiographic disease progression (up to approximately 55 months)

  20. TTRP as Determined by The IRF According to HCC-Specific mRECIST (Arm A and Arm F)

    Measured: From the first dose of study treatment (Arm A) or randomization (Arm F) to the first occurrence of radiographic disease progression (up to approximately 55 months)

  21. Percentage of Participants With Anti-Therapeutic Antibodies (ATAs)

    Measured: Predose (0 h) on Day 1 of Cycles 1, 2, 3, 4, 8 and every 8 cycles until treatment discontinuation (up to 55 months); at 120 days after last dose (Cycle length =21-28 days; up to 55 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2016 (estimated)
  2. Study start6 Apr 2016
  3. Primary completion31 May 2021
  4. Study completion31 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
243 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02715531
Sponsor's protocol ID
GO30140
Status last verified
Jul 2021
First submitted
17 Mar 2016
Last updated
9 Jul 2021
Results posted
No

Publications

  • Lee MS, Ryoo BY, Hsu CH, Numata K, Stein S, Verret W, Hack SP, Spahn J, Liu B, Abdullah H, Wang Y, He AR, Lee KH; GO30140 investigators. Atezolizumab with or without bevacizumab in unresectable hepatocellular carcinoma (GO30140): an open-label, multicentre, phase 1b study. Lancet Oncol. 2020 Jun;21(6):808-820. doi: 10.1016/S1470-2045(20)30156-X.

    PubMed 32502443

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 5-FU, Atezolizumab and Bevacizumab in people with Solid Tumor, run by Hoffmann-La Roche at 30 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 36 inclusion and 53 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States, South Korea, Taiwan, Japan, Australia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With At Least One Adverse Event, with Severity Determined According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (time frame: From screening to up to 90 days after the last dose of study drug (up to approximately 55 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02715531, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2021.

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