A Trial of LNS8801 With or Without Pembrolizumab in Patients With Refractory Melanoma

ConditionsMelanoma (Skin Cancer)Melanoma Stage IIIB-IV Cutaneous Melanoma Unresectable Melanoma

Trial statusRecruiting

Trial phasePhase 2, Phase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorLinnaeus Therapeutics, Inc.

About this trial

The goal of this clinical trial is to understand if a new drug called LNS8801 can safely treat patients with melanoma. The primary question to be answered is what is the average length of time during which melanoma does not grow or spread after starting treatment with LNS8801? Researchers will compare LNS8801 taken alone or LNS8801 taken together with another drug called pembrolizumab to other therapies as decided by the treating doctor.

135 patients will be randomly (like flipping a coin) placed in 3 treatment groups.

In the first group (LNS8801 only) - Patients will take 125mg tablet of LNS8801 by mouth once per day every day for up to 2 years.

In the second group (LNS8801 + pembrolizumab) - Patients will take 125mg tablet of LNS8801 by mouth once per day plus 200 mg of pembrolizumab by IV infusion once every 3 weeks for up to 2 years.

In the third group, called Physician's Choice (PC), patients will receive chemotherapy (dacarbazine or temozolomide) or immunotherapy (pembrolizumab, nivolumab/relatlimab or nivolumab/ipilimumab) as determined by their treating physician.

How often the patient visits the clinic visits will depend on the treatment group. Besides returning to the clinic for treatment, the patient will undergo periodic safety assessments and other required study procedures such as imaging assessments.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

LNS8801
Biological/Vaccine
G protein-coupled estrogen receptor (GPER) agonist
Pembrolizumab
Biological/Vaccine
Recombinant monoclonal antibody (anti-PD1)
Chemotherapy (dacarbazine or temozolomide)
Drug
chemotherapy (dacarbazine, temozolomide)
Immunotherapy (Pembrolizumab)
Biological/Vaccine
pembrolizumab
Immunotherapy (nivolumab and relatlimab)
Biological/Vaccine
nivolumab and relatlimab
Immunotherapy (ipilimumab and nivolumab)
Biological/Vaccine
ipilimumab and nivolumab

Treatment groups

135 Participants

are divided into 3 treatment groups

Group A: LNS8801 MonotherapyExperimental treatment 1 intervention

Group B: LNS8801 + PembrolizumabExperimental treatment 2 interventions

Group C: Physician's ChoiceActive comparator 4 interventions

Trial outcomes

Primary outcomes

Compare progression-free survival (PFS) of LNS8801 + pembrolizumab vs PC arms as assessed by RECIST v1.1.

Compare PFS between each of the 3 arms

Time frame

up to 2 years.

Secondary outcomes

Overall Survival (OS) of LNS8801 + pembrolizumab with PC treatment

Median OS compared between each of the 3 arms.

Time frame

up to 5 years after the end of treatment

Hospitalization days of LNS8801 + pembrolizumab vs LNS8801 monotherapy vs PC arms.

compare length of hospital stays between each of 3 arms

Time frame

Length of hospital stay (assessed up to 10 days)

Duration of Response (DOR) of LNS8801 + pembrolizumab vs LNS8801 monotherapy vs PC arms.

Duration partial response or complete response by RECIST v1.1. DOR compared between each of the 3 arms

Time frame

up to 2 years.

Overall Response Rate (ORR) of LNS8801 + pembrolizumab vs LNS8801 monotherapy vs PC arms.

ORR is defined as partial response or complete response by RECIST v1.1. ORR compared between each of the 3 arms

Time frame

up to 2 years

Other outcomes

OS in patients treated beyond progression vs those who stopped treatment at progression.

Median OS compared between patients treated beyond progression and those who stopped treatment without progression.

Time frame

up to 5 years after the end of treatment

Change in quality of life (QOL) survey responses during therapy (QLQ-C30 questionnaire) on therapeutic intervention in LNS8801 + pembrolizumab vs LNS8801 monotherapy vs PC arms.

Compare between each of the 3 arms

Time frame

At the beginning of Cycle 1 (each cycle 6 weeks), 2, and 3 then every 12 weeks for 1 year

Subgroup analyses comparing patients with primary vs secondary resistance to prior PD-1 therapy, LDH, and extent of disease.

Patients will be stratified by normal or elevated baseline LDH, less than 3 or ≧3 disease sites, and physician's determination of primary vs secondary anti-PD-1 therapy resistance as per SITC guidance

Time frame

Collected at screening

Changes in overall health measures (blood pressure).

Blood draw collected at screening and then every 6 weeks starting with Cycle 1.

Time frame

Screening visit 2 and every 6 weeks up to on average 2 years.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Linnaeus Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov

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