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New treatment option for Advanced Solid Tumor
Official title A Modular Multi-Basket Trial to Improve Personalized Medicine in Cancer Patients (Basket of Baskets)
ClinicalTrials.gov ID: NCT03767075
What this study is testing
What is Atezolizumab?
Atezolizumab is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for advanced solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The global objective of this Basket of Basket study is to evaluate the antitumor activity of each matched therapies that will be evaluated through the study in small molecularly selected populations. The objective of module 1 wil be to determine the overall response rate (ORR) at 12 weeks by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of atezolizumab in each of the arms of the module.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Eligibilty Criteria (PART A - iPROFILER)
- people must have histologically or cytologically confirmed malignancy that is metastatic or unresectable, who have progressed to standard therapy...
- Patient must have ECOG performance status of 0 or 1.
- people must be 18-year-old or older.
- people must have measurable disease according to RECIST 1.1.
You likely can't join if
- people with leptomeningeal disease should be excluded from this clinical trial.
- people with known unstable brain metastases should be excluded from this clinical trial. Exception: people who have undergone surgery and/or...
- people with spinal cord compression not definitively treated with surgery and/or radiation.
- people with uncontrolled intercurrent illness including, but not limited to, active infection, symptomatic congestive heart failure, LVEF \< 50%...
- people with inability to swallow tablets or capsules.
- people with known HIV, hepatitis B or hepatitis C infection.
See the full eligibility criteria
Who can join
- Eligibilty Criteria (PART A - iPROFILER)
- people must have histologically or cytologically confirmed malignancy that is metastatic or unresectable, who have progressed to standard therapy, who are receiving a standard anticancer treatment, but no subsequent...
- Patient must have ECOG performance status of 0 or 1.
- people must be 18-year-old or older.
- people must have measurable disease according to RECIST 1.1.
- people must have enough tumour tissue for molecular analysis.
- people providing formalin-fixed paraffin embedded tissue (FFPE) must provide a minimum amount of tissue ranging from 28 to 36 slides depending on the sample tumour cellularity. If there is not enough archival tissue to...
- people providing fresh frozen tissue must provide 5 core biopsies or equivalent. Fresh frozen tissue must be preferentially collected from a tumour biopsy; hence, people must have disease amenable to be biopsied...
- Efforts will be made to provide fresh frozen tissue in at least one quarter of the participating people. The proportion of people that might provide fresh frozen tissue might change based on the results from the...
- Since some of the tests are performed in FFPE tissue, people providing fresh frozen tissue from a recent biopsy will have part of the sample processed in FFPE as per Laboratory manual.
- people must have adequate haematological, renal, and hepatic function.
- For people requiring a tumour biopsy: people must have adequate coagulation function.
- people must be willing to participate in a clinical trial with a matched therapy according to the molecular profile of his/her tumour.
What rules you out
- people with leptomeningeal disease should be excluded from this clinical trial.
- people with known unstable brain metastases should be excluded from this clinical trial. Exception: people who have undergone surgery and/or radiotherapy and in which brain metastases remain stable or decrease in size...
- people with spinal cord compression not definitively treated with surgery and/or radiation.
- people with uncontrolled intercurrent illness including, but not limited to, active infection, symptomatic congestive heart failure, LVEF \< 50%, unstable angina pectoris, cardiac arrhythmia, or psychiatric...
- people with inability to swallow tablets or capsules.
- people with known HIV, hepatitis B or hepatitis C infection.
- people with known history of malabsorption. Eligibilty Criteria (PART B - iBASKET) Inclusion Criteria:
- people must have metastatic or unresectable malignant tumour, histologically or cytological confirmed and progressing to current therapy. Tumours must be refractory to standard therapy or for which standard therapy does...
- Patient must have ECOG performance status of 0 or 1.
- people must be 18-year-old or older.
- people must have measurable disease according to RECIST 1.1.
- people must be willing to participate in a clinical trial with a matched therapy according to the molecular profile of his/her tumour.
- Tumours must harbour the following alterations.
- people must have adequate hematological, renal, and hepatic function.
- For people requiring a tumour biopsy: people must have adequate coagulation function.
- A woman of childbearing potential must have a negative serum pregnancy test within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy test during the study.
- A woman must be either of the following:
- Not of childbearing potential.
- Of childbearing potential and practicing true abstinence during the entire period of the study, including up to 6 months after the last dose of study treatment is given.
- Of childbearing potential and practicing 2 methods of contraception, including 1 highly effective user independent method and a second method. Participant must agree to continue contraception throughout the study and...
- A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 6 months after receiving the last dose of study treatment.
- A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 6 months after receiving the last dose of study treatment.
- Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria:
- Pregnant or breastfeeding women. Females of childbearing potential must have a negative serum pregnancy test within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy test...
- Any approved anticancer therapy, including chemotherapy, hormonal therapy or radiotherapy, within 3 weeks prior to initiation of study treatment; however, the following are allowed:
- Hormone-replacement therapy or oral contraceptives.
- Somatostatin analogues for the treatment of symptoms related with neuroendocrine tumours.
- Gonadotropin-releasing hormone agonists or antiandrogens for prostate cancer.
- Palliative radiotherapy for bone metastases \> 2 weeks prior to Cycle 1, Day 1.
- Treatment with an investigational agent within 3 weeks prior to Cycle 1, Day 1 (or within five half-lives of the investigational product, whichever is longer).
- Patients with recent major surgery or invasive procedure within 15 days before the fist dose of the study drug.
- Participant has unstable symptomatic brain metastases. A participant with asymptomatic or previously treated and stable brain metastases may participate in this study. a. Participants who have received definitive...
- Patients with meningeal or leptomeningeal carcinomatosis.
- Uncontrolled intercurrent illness including, but not limited to, active infection, cardiovascular disease, or psychiatric illness/social situations that would limit compliance with study requirements.
- Positive hepatitis B (hepatitis B virus [HBV]) surface antigen (HBsAg). Note: people with a prior history of HBV demonstrated by positive hepatitis B core antibody are eligible if they have at Screening 1) a negative...
- Positive hepatitis C antibody (anti-HCV). Note: people with a prior history of HCV, who have completed antiviral treatment and have subsequently documented HCV RNA below the lower limit of quantification per local...
- Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class III or greater), myocardial infarction within 3 months prior to Cycle 1, Day 1, unstable angina or unstable clinically...
- Another primary malignancy other than disease under study within 2 years prior to Cycle 1 Day 1, unless consider at low risk of relapse at Investigator discretion.
- Contraindications included in the product information of the drugs used in the study. Other protocol specified criteria for each module. The study center will determine if criteria for participation are met.
The study team makes the final eligibility decision.
Where it's taking place
- Villejuif, France
- Heidelberg, Baden-Wurttemberg, Germany
- Dresden, Germany
- Milan, Italy
- Amsterdam, Netherlands
- Barcelona, Spain
- Stockholm, Sweden
- Cambridge, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Villejuif, France; Heidelberg, Baden-Wurttemberg, Germany; Dresden, Germany; Milan, Italy; Amsterdam, Netherlands; Barcelona, Spain and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.