A Clinical Study of Calderasib (MK-1084) in People With Advanced Solid Tumors (MK-1084-014)
ConditionNeoplasm Malignant
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMerck Sharp & Dohme LLC
About this trial
Researchers want to learn if calderasib given alone or with cetuximab can treat certain advanced solid tumors in people with the KRAS G12C mutation.
The goals of this study are to learn:
* How many people have the cancer respond (get smaller or go away) to calderasib alone or with cetuximab and how these responses compare * About the safety of calderasib alone or with cetuximab and if people tolerate the treatments.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Has locally advanced unresectable or metastatic solid tumor malignancy other than colorectal cancer and has progressed on, or following, standard of care systemic treatment
Has a tumor that demonstrates the presence of Kirsten rat sarcoma (KRAS) G12C mutation
Disqualifiers
Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
Has known additional malignancy that is progressing or has required active treatment within the past 3 years
Has known active central nervous system metastases and/or carcinomatous meningitis and/or primary brain tumors
Has active infection, other than those permitted per protocol, requiring systemic therapy
Trial design
Design model
Parallel
Treatments tested in this trial
Calderasib
DrugOral administration
Cetuximab
Biological/VaccineIntravenous administration
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: CalderasibExperimental treatment 1 intervention
Group B: Calderasib + CetuximabExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Objective Response Rate (ORR)
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
Time frame
Up to approximately 76 months2
Number of Participants Who Experience One or More Adverse Events (AEs)
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience an AE will be reported.
Time frame
Up to approximately 76 months3
Number of Participants Who Discontinue Study Treatment Due to an AE
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinue study treatment due to an AE will be reported.
Time frame
Up to approximately 76 monthsSecondary outcomes
1
Progression-free Survival (PFS)
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by RECIST 1.1. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) will be presented.
Time frame
Up to approximately 76 months2
Duration of Response (DOR)
For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.
Time frame
Up to approximately 76 months3
Overall Survival (OS)
OS is defined as the time from randomization to the date of death due to any cause. OS will be presented.
Time frame
Up to approximately 76 monthsSponsors and contacts
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Source ClinicalTrials.gov