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A trial to learn how well NMS-01940153E works in combination with atezolizumab and priming administration of decitabine or with atezolizumab alone in patients with hepatocellular carcinoma (HCC) that cannot be removed by surgery and who received prior treatment with other anti-cancer medicines
EU CTIS ID: 2024-516737-12-00
What this study is testing
To determine the antitumor activity of NMS-01940153E administered with the immune checkpoint inhibitor (ICI) atezolizumab with (Part A, B) or without (Part C) low dose decitabine priming to adult patients with unresectable HCC previously treated with immune checkpoint inhibitors
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Histological, cytological, or radiological diagnosis of HCC, according to the American Association for the Study of Liver Diseases/European Association for the Study of the Liver criteria.
- 10. Aged ≥18 years old on day of consent.
- 2. Disease that is not amenable to a curative treatment approach (eg, transplant, surgery, radiofrequency ablation) and unsuitable for or refractory to locoregional treatments (eg, transarterial chemoembolization).
- 3. At least 1 unidimensional measurable lesion by computed tomography, positron emission tomography, or magnetic resonance imaging according to RECIST 1.1 which is either not previously treated by local therapy or, if treated, it has clearly progressed before the patient is recruited.
- 4. Had received only one line of prior treatment including atezolizumab plus bevacizumab or other approved check-point inhibitor (ICI) combination as 1st line.
- 5. Patients treated with the prior ICI must have received at least 4 consecutive treatment cycles, and 2 subsequent tumor assessments. It is required that at least 1 tumor assessment showed either stable disease (SD), partial response (PR), or complete response (CR) while on treatment with prior ICI.
You likely can't join if
- 1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed hepatocholangiocarcinoma.
- 2. Previous history or actual presence of varices, unless this medical condition is stable with optimal medical management (eg, non-selective beta blocker, proton pump inhibitor) and there is no active or a prior documented gastrointestinal bleeding episode (eg, esophageal varices or ulcer bleeding) within the last 12 months.
- 3. QT interval corrected by Fridericia ≥480 ms or with risk factors for Torsade de Pointes (eg, heart failure, uncontrolled hypokalemia, family history of long QT syndrome) or receiving treatment with concomitant medications known to prolong the QT/corrected QT interval that cannot be replaced with another treatment.
- 4. Ascites defined as National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥2.
- 5. Uncontrolled high blood pressure (systolic blood pressure >150 mmHg and/or diastolic blood pressure >95 mmHg, despite optimal treatment, on at least 2 out of 3 determinations repeated at 30 minute intervals and done in case that the first 1 meets the criterion for exclusion).
- 6. Recent history of hepatic encephalopathy Grade ≥2.
See the full eligibility criteria
Who can join
- 1. Histological, cytological, or radiological diagnosis of HCC, according to the American Association for the Study of Liver Diseases/European Association for the Study of the Liver criteria.
- 10. Aged ≥18 years old on day of consent.
- 2. Disease that is not amenable to a curative treatment approach (eg, transplant, surgery, radiofrequency ablation) and unsuitable for or refractory to locoregional treatments (eg, transarterial chemoembolization).
- 3. At least 1 unidimensional measurable lesion by computed tomography, positron emission tomography, or magnetic resonance imaging according to RECIST 1.1 which is either not previously treated by local therapy or, if treated, it has clearly progressed before the patient is recruited.
- 4. Had received only one line of prior treatment including atezolizumab plus bevacizumab or other approved check-point inhibitor (ICI) combination as 1st line.
- 5. Patients treated with the prior ICI must have received at least 4 consecutive treatment cycles, and 2 subsequent tumor assessments. It is required that at least 1 tumor assessment showed either stable disease (SD), partial response (PR), or complete response (CR) while on treatment with prior ICI.
- 6. Patients must have confirmation of radiological progression on prior ICI treatment before inclusion.
- 7. Barcelona Clinic Liver Cancer stage B (that is not eligible for locoregional therapy) or stage C.
- 8. Eastern Cooperative Oncology Group performance status of 0 or 1.
- 9. Child-Pugh score of A within 7 days prior to enrollment.
What rules you out
- 1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed hepatocholangiocarcinoma.
- 2. Previous history or actual presence of varices, unless this medical condition is stable with optimal medical management (eg, non-selective beta blocker, proton pump inhibitor) and there is no active or a prior documented gastrointestinal bleeding episode (eg, esophageal varices or ulcer bleeding) within the last 12 months.
- 3. QT interval corrected by Fridericia ≥480 ms or with risk factors for Torsade de Pointes (eg, heart failure, uncontrolled hypokalemia, family history of long QT syndrome) or receiving treatment with concomitant medications known to prolong the QT/corrected QT interval that cannot be replaced with another treatment.
- 4. Ascites defined as National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥2.
- 5. Uncontrolled high blood pressure (systolic blood pressure >150 mmHg and/or diastolic blood pressure >95 mmHg, despite optimal treatment, on at least 2 out of 3 determinations repeated at 30 minute intervals and done in case that the first 1 meets the criterion for exclusion).
- 6. Recent history of hepatic encephalopathy Grade ≥2.
- 7. Patients with prior administration of a tyrosine kinase inhibitor (TKI) in advanced disease.
- 8. Patients with previous episodes (minimum of 1 episode) of neutropenia grade 3 and 4 related to therapeutic treatment for HCC.
The study team makes the final eligibility decision.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.