Anti-PD1-antibody and Pulsed HHI for Advanced BCC (NCT04679480) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Anti-PD1-antibody and Pulsed HHI for Advanced BCC
Switzerland20 participantsStarted 2021-02-18
Plain-language summary
The purpose of this study is to evaluate the tumour response, safety and induction of immune response in patients with advanced BCC treated with a combination of anti-PD1 antibody and pulsed hedgehog inhibitor.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Informed Consent as documented by signature
* Histologically or cytologically confirmed advanced BCC, defined as: a) metastasized BCC, b) locally advanced BCC, not suitable for surgical or radio-therapeutic treatment c) multiple BCCs (\>5) d) BCC \>10mm; not suitable for surgery or radiotherapy
* Subjects must have an evaluable disease as measured by Immune-related Response criteria, or PERSIST (PET response criteria in solid tumours) criteria in patients with metastatic BCCs without cutaneous lesions.
* Subjects (males and females) aged ≥ 18 years
* Adequate organ function (hematologic, renal, hepatic), as assessed by the study physician. Deviations of the following parameters are allowed upon decision of the investigator in case that these are not considered to be of clinical relevance and/or don't represent organ dysfunction or correspond to allowed comorbidities as specified in section 7.1:
* Absolute neutrophil count \>1.5 x 109/l
* Hemoglobin \>9 g/dL
* Platelets ≥ 100 x 109/l
* Serum total bilirubin \<1.5 x Upper limit of normal (ULN) (or ≤3x ULN, if liver metastases).
* Alanine transaminase (ALT) and Aspartate transaminase (AST) \< 3 x ULN or \<5 ULN if liver metastases are present
* Patients with Gilbert's Disease and total bilirubin up to 3x ULN may be eligible after communication with and approval from the medical monitor
* Alkaline phosphatase (ALP) ≤2.5x ULN (or ≤5x ULN, if liver or bone metastases)
* Serum creatinine \< 2 x ULN
* Creatine …
What they're measuring
1
Best response any time between the treatment start and 26 weeks after the initiation of the treatment.
Timeframe: At baseline, each assessment and the week 26.