Trial NCT06624644
A Trial of LNS8801 With or Without Pembrolizumab in Patients With Refractory Melanoma
- Phase
- Phase 2/3
- Sponsor
- Linnaeus Therapeutics, Inc.
- Conditions
- Melanoma (Skin Cancer); Melanoma Stage IIIB-IV; Cutaneous Melanoma; Unresectable Melanoma
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
Inclusion Criteria:
* Confirmed unresectable and/or metastatic cutaneous melanoma.
* 2 copies of the fully functional form of GPER protein-coding sequence.
* Eligible for and willing to receive 1 or more of the physician's choice (PC) therapies.
* Able to swallow tablets.
* Progressed on treatment with an anti-PD-1 monoclonal antibody (mAb) administered either as monotherapy or in combination with other therapies.
* Received an anti-CTLA-4 and/or BRAF containing regimen or is not eligible for or has declined anti-CTLA-4 and/or BRAF therapy prior to and for this study.
* Measurable disease.
* Eastern Cooperative Oncology Group Performance Status of 0 to 1.Performance status
Exclusion Criteria:
* Blue nevus subtype, mucosal, acral lentiginous, or uveal/ocular/choroidal Melanoma.
* Previous anti-cancer or investigational drug/device treatment within 4 weeks of the first dose of study drug.
* Radiotherapy within 2 weeks of starting study drug.
* Allogeneic tissue/solid organ transplant.
* Unstable autoimmune or immunodeficiency disease.
* Other concurrent health issues that would make participation or completion of the study difficult.
* Prior reaction to anti PD-1 therapy that would make treatment with pembrolizumab unadvisable.
* Other protocol-defined inclusion/exclusion criteria may apply.
Restrictions found (1)
- Performance statusOutrightinclusion
ECOG 0 to 1
Show in the text
Recruiting in Massachusetts
- Dana Farber · Boston, Suffolk County