A clinical trial to look at how well RO6874281 works in combination with another drug called atezolizumab to slow, stop or reverse the course of solid tumours

Study to Evaluate the Therapeutic Activity of RO6874281 as a Combination Therapy in Participants With Advanced and/or Metastatic Solid Tumors

  • Cancer
Trial Status:

Completed

This trial runs in
Cities
  • Adana
  • Antalya
  • Auckland
  • Barcelona
  • Bordeaux
  • Edegem
  • Edirne
  • Essen
  • Gdańsk
  • Gent
  • Genève
  • Haifa
  • İstanbul
  • İzmir
  • Leuven
  • London
  • Madrid
  • Manchester
  • Marseille
  • Montpellier
  • Moscow
  • Newnan
  • Pamplona
  • San Francisco
  • Seongnam-si
  • Seoul
  • Singapore
  • Sutton
  • Tainan City
  • Taipei City
  • València
  • Villejuif
  • Warszawa
Trial Identifier:

NCT03386721 2017-003182-94 BP40234

      Show trial locations

      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

      Results Disclaimer

      Trial Summary

      This is an open-label, multicenter, basket trial Phase II study to evaluate the antitumor activity of simlukafusp alfa in combination with atezolizumab in participants with advanced and/or metastatic solid tumors. Currently the focus is on patients with Head and Neck, oesophageal and cervical cancers with confirmed squamous cell carcinoma histology type.

      Hoffmann-La Roche Sponsor
      Phase 2 Phase
      NCT03386721 , BP40234 , 2017-003182-94 Trial Identifier
      All Gender
      ≥ 18 Years Age
      No Healthy Volunteers

       

      How does the BP40234 clinical trial work?
      This clinical trial is recruiting people who have solid tumours (cancer) that are advanced or have spread (‘metastatic’). Solid tumours can include lung cancer, cancers of the head and neck, oesophageal (throat) cancer, cervical cancer or a cancer that starts in another organ. Advanced or metastatic are terms used to describe a tumour that has spread beyond the original cancer site to other parts of the body.

      The purpose of this clinical trial is to compare the effects, good or bad, of RO6874281 plus atezolizumab in patients with advanced or metastatic solid tumours. By giving the two drugs together it is hoped that the effects are greater than giving each drug on its own.

      In this clinical trial, you will get a combination of RO6874281 plus atezolizumab. The exact treatment schedule will depend on which group you are allocated to (and this depends on your type of cancer and, in some cases, the type of treatment that you have already received for your tumour).

      How do I take part in this clinical trial?
      To be able to take part in this clinical trial, you must have an advanced or metastatic solid tumour, and be at least 18 years old.

      You will not be able to take part if your tumour has spread to your brain or spinal cord and (1) you are experiencing symptoms caused by this, or (2) if you haven’t yet received treatment for the cancer in your brain/spinal cord.

      If you think this clinical trial may be suitable for you and would like to take part, please talk to your doctor. If your doctor thinks that you might be able to take part in this clinical trial, he/she may refer you to the closest clinical trial doctor. They will give you all the information you need to make your decision about taking part in the clinical trial. You can also find the clinical trial locations on this page.

      You will have some further tests to make sure you will be able to take the treatments given in this clinical trial. Some of these tests or procedures may be part of your regular medical care. They may be done even if you do not take part in the clinical trial. If you have had some of the tests recently, they may not need to be done again.

      Before starting the clinical trial, you will be told about any risks and benefits of taking part in the trial. You will also be told what other treatments are available so that you may decide if you still want to take part.

      While taking part in the clinical trial, both men and women (if you are not currently pregnant but can become pregnant) will need to either not have heterosexual intercourse or take contraceptive medication for safety reasons.

      What treatment will I be given if I join this clinical trial?
      The majority of patients who join this clinical trial will be given RO6874281 plus atezolizumab, with both infused into a vein in your arm. The exact treatment that you will receive depends on the group you are allocated to, but will be based on one of two schedules:

      • RO6874281 every week plus atezolizumab every 2 weeks for 4 weeks, then RO6874281 plus atezolizumab every 2 weeks
      • RO6874281 plus atezolizumab every 3 weeks

      Your group will depend on your type of cancer, and in some cases, the type of treatment that you have already received. In some groups, you may be randomly allocated to RO6874281 plus atezolizumab or another ‘control’ treatment. Your study doctor will explain to you your group allocation and the treatment you will receive.

      How often will I be seen in follow-up appointments and for how long?
      You will be given the clinical trial treatment for as long as it helps you. You are free to stop treatment at any time. After being given treatment, you will still be seen regularly by the clinical trial doctor. These hospital visits will include checks to see how you are responding to the treatment and any side effects that you may be having. After being given your last dose, you will be seen by the clinical trial doctor after about 1 month, 3 months and 4 months.

       

      What happens if I am unable to take part in this clinical trial?
      If this clinical trial is not suitable for you, you will not be able to take part. Your doctor will suggest other clinical trials that you may be able to take part in or other treatments that you can be given. You will not lose access to any of your regular care.

      For more information about this clinical trial see the For Expert tab on the specific ForPatient page or follow this link to ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT03386721

      Trial-identifier: NCT03386721

      Trial Summary

      This is an open-label, multicenter, basket trial Phase II study to evaluate the antitumor activity of simlukafusp alfa in combination with atezolizumab in participants with advanced and/or metastatic solid tumors. Currently the focus is on patients with Head and Neck, oesophageal and cervical cancers with confirmed squamous cell carcinoma histology type.

      Hoffmann-La Roche Sponsor
      Phase 2 Phase
      NCT03386721 , BP40234 , 2017-003182-94 Trial Identifier
      Simlukafusp Alfa (RO6874281), Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody, Gemcitabine, Vinoralbine Treatments
      Solid Tumors Condition
      Official Title

      An Open-Label, Multicenter, Phase II Study to Evaluate the Therapeutic Activity of Simlukafusp Alfa (RO6874281), an Immunocytokine, Consisting of Interleukin-2 Variant (IL-2v) Targeting Fibroblast Activation Protein-Α (FAP), in Combination With Atezolizumab (Anti-PD-L1), Administered Intravenously, in Participants With Advanced and/or Metastatic Solid Tumors

      Eligibility Criteria

      All Gender
      ≥ 18 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Participants who have progressed on at least one previous regimen of anticancer therapy (chemotherapy, mutation targeted therapy, and/or CPI therapy)
      • Measurable disease, as defined by RECIST Version 1.1
      • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 or Karnofsky Performance Score greater than or equal to (>=) 70
      • Life expectancy of >=12 weeks
      • Confirmed at least one tumor lesion with location accessible to safely biopsy per clinical judgment of the treating physician.

      Biopsies are not applicable to participants in Cohorts G, H, K, and L presenting with a single target lesion and absence of any non-target lesion.

      • Consent to provide an archival tumor tissue sample (if available, applicable to all participants)
      • Willingness to undergo baseline and on-treatment tumor biopsies for pharmacodynamics (PD) biomarker analysis (biopsies are optional for Cohort A)
      • Adequate cardiovascular function as defined in the study protocol
      • AEs related to any previous 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 haematological, liver, and renal functions.
      • Participants with unilateral pleural effusion (indications other than NSCLC) are eligible if they fulfill both of the following:

      1. NYHA Class 1

      2. Forced expiratory volume 1 (FEV1) and forced vital capacity (FVC) >70% of predicted value; participants with lung metastases should present with DLCO >60% of predicted value.

      • Participants with Gilbert's syndrome will be eligible for the study
      • Participants must have had confirmed diagnosis of recurrent or metastatic squamous cell carcinoma head and neck, or esophageal cancer or metastatic, persistent or recurrent squamous cervical cancer.
      Exclusion Criteria
      • Symptomatic or untreated central nervous system (CNS) metastases
      • History of treated asymptomatic CNS metastases as described in the protocol
      • 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 before enrollment
      • Leptomeningeal disease
      • An active second malignancy
      • Penetrating tumor infiltration
      • Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
      • Episode of significant cardiovascular/cerebrovascular acute disease within 6 months before study treatment administration
      • History of significant vascular disease (for example, aortic aneurysm, aortic dissection)
      • Active or uncontrolled infections
      • Human immunodeficiency virus (HIV) or Active Hepatitis A, B, C, D or E infection (HAV/HBV/HCV/HDV/HEV).
      • Severe infection within 4 weeks before study treatment administration including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia.
      • History of chronic liver disease or evidence of hepatic cirrhosis
      • Dementia or altered mental status that would prohibit informed consent
      • History of, active or suspicion of autoimmune disease
      • History of idiopathic pulmonary fibrosis, pneumonitis (including drug-induced), organizing pneumonia (bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
      • Bilateral pleural effusion confirmed by X-ray
      • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that give reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug
      • Concurrent therapy with any other investigational drug
      • Immunomodulating agents as described in study protocol
      • Chronic use of steroids
      • Last dose with any cytostatic treatments < 28 days before study treatment administration
      • Radiotherapy within the last 4 weeks before start of study treatment administration, with the exception of limited field palliative radiotherapy
      • Administration of a live, attenuated vaccine within 4 weeks before Cycle 1 Day 1 or at any time during the study and 5 months after the last dose of atezolizumab
      • Major surgery or significant traumatic injury <28 days before study treatment administration (excluding fine needle biopsies) or if wound healing has not completed after surgery or anticipation of the need for major surgery during study treatment
      • Known hypersensitivity to any of the components of the simlukafusp alfa drug product or atezolizumab drug product
      • Severe dyspnea at rest or requiring supplementary oxygen therapy Locally curative options are available for participant's disease.

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