Health TrialsbyHealthPanel

XL092 and Cemiplimab in BRAF WT Thyroid Cancer

ConditionsAnaplastic Thyroid CancerThyroid CancerBRAF Mutation-Related Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUNC Lineberger Comprehensive Cancer Center

About this trial

This multicenter study examines the safety and feasibility of the combination of neoadjuvant XL092 and cemiplimab prior to surgical resection in participants with wild-type (WT) anaplastic thyroid cancer (ATC) that has a BRAF mutation (BRAF V600E).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent was obtained to participate in the study and HIPAA authorization for the release of personal health information.

Subjects are willing and able to comply with study procedures based on the judgment of the investigator.

Age ≥ 18 years at the time of consent.

the Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.

Disqualifiers

Pregnant or breastfeeding (Note: breast milk cannot be stored for future use while the mother is being treated on the study). Females should not breastfeed while receiving study treatment and for 1 month from the last dose of XL092.

Patients who have had prior exposure to any immune modulating agents or any type of small molecule kinase inhibitor (including investigational agents) and have documented disease progression on these agents will not be eligible.

Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments (i.e., with use of disease modifying agents, corticosteroids (>10 mg of prednisone or equivalent) or immunosuppressive drugs) which may suggest risk of immune-mediated Adverse Events.

Replacement therapy (e.g.: thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. The following are not exclusionary: vitiligo, childhood asthma that has resolved, type 1 diabetes, residual hypothyroidism that required only hormone replacement, or psoriasis that does not require systemic treatment.

Trial design

Design model

Single group

Treatments tested in this trial

  • Cemiplimab

    Biological/Vaccine

    Cemiplimab will be administered at a dose of 350mg intravenous over 30 minutes every 3 weeks for 3 cycles (cycle length is 21 days) at weeks 1, 4, and 7.

  • XL092

    Drug

    XL092 will be administered at a dose of 60mg PO daily for 8 weeks (weeks 1-8)

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: neoadjuvant XL092 and cemiplimabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Complete gross resection

Complete gross resection (CGR) is defined as the proportion of patients who undergo successful thyroidectomy with negative (R0) or microscopically positive (R1) surgical margins.

Time frame
12 weeks
2

Non-hematologic treatment related adverse events (TRAEs)

Non-hematologic treatment related adverse events (TRAEs) with neoadjuvant and maintenance XL092 and cemiplimab will be classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI- CTCAE) v5.0.

Time frame
Up to 2 years

Secondary outcomes

1

Objective response rate (ORR)

Objective response rate (ORR) following neoadjuvant therapy prior to surgery as defined as a partial or complete response per Radiographic response will be measured by RECIST, 1.1 criteria. Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no response or less response than Partial or Progressive; or Progressive Disease (PD), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Time frame
10 weeks
2

Time to surgery

Time to surgery following completion of neoadjuvant XL092 and cemiplimab will be defined as the time from completion of neoadjuvant therapy to date of surgery. Participants who do not receive surgery due to progressive disease or non-treatment-related adverse events death will not be counted.

Time frame
12 weeks
3

The rate of pathologic response

The rate of pathologic response will be defined as either a pathological complete response (pCR), which is the absence of a residual viable tumor or a major pathological response (MPR), which is \< 10% residual tumor following neoadjuvant therapy and surgery.

Time frame
12 weeks
4

Conversion rate from unresectable to resectable disease

Conversion rate from unresectable to resectable disease will be defined as the number of subjects with unresectable disease at the time of screening who are deemed to have resectable disease at the completion of neoadjuvant therapy.

Time frame
12 weeks

Other outcomes

Sponsors and contacts

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

UNC Lineberger Comprehensive Cancer Center

Lead sponsor

Regeneron Pharmaceuticals

Collaborator

Exelixis

Collaborator

Source ClinicalTrials.gov
Apply now