Trial Title:
A Study of IO102/IO103, Nivolumab, and Relatlimab in People With Melanoma
NCT ID:
NCT05912244
Condition:
Melanoma
Conditions: Official terms:
Melanoma
Nivolumab
Relatlimab
Conditions: Keywords:
IO102/IO103
Nivolumab
Relatlimab
Unresectable
Stage III/IV
23-098
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Intervention model description:
Sequentially in a single-arm, nonrandomized two-stage trial design
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
IO102/IO103
Description:
IO102/IO103 will be administered subcutaneously on Days 1 and 15 of the first two 28-day
cycles, and then on Day 1 only of subsequent cycles for two total years of treatment.
Each vaccine contains 85ug.
Arm group label:
IO102/IO103, Nivolumab, and Relatlimab
Intervention type:
Drug
Intervention name:
Nivolumab-Relatlimab
Description:
Nivolumab-relatlimab will be administered as a single infusion 160mg relatlimab and
nivolumab 480 mg for all participants. Both agents will be combined in a single
fixed-dose combination (FDC) as an intravenous 30-minute infusion every four weeks.
Arm group label:
IO102/IO103, Nivolumab, and Relatlimab
Summary:
The researchers are doing this study to find out whether the study vaccines, IO102/IO103,
given in combination with the standard-of-care drug combination, nivolumab and
relatlimab, is a safe and effective treatment for people with untreated, unresectable
melanoma.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≥ 18 years at the time of informed consent
2. Patient must be able to provide informed consent.
3. Patient must have a histologically confirmed diagnosis of locally advanced
unresectable stage III or metastatic stage IV melanoma not amenable to local
therapy.
4. Patient must have not received any prior systemic therapy directed against
unresectable stage III or IV melanoma. Prior neoadjuvant and adjuvant ICIs and
BRAF/MEK inhibitors are permitted as long as the last dose was > 6 months prior to
recurrence.
5. Patients must have at least one extraskeletal, extracranial measurable melanoma
lesion as defined by RECIST v1.1. Note: A formal RECIST read by a study radiologist
is not needed at the time of enrollment. Measurable disease can be assessed by the
treating investigator.
6. Patients must have Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
7. Adequate laboratory function at screening, defined as:
1. Hemoglobin ≥ 9.0 g/dL
2. WBC ≥ 2000/uL
3. Platelet count ≥ 100 × 10^9 /L
4. Serum direct bilirubin ≤ 1.5 × upper limit of normal (ULN); AST and ALT ≤ 2.5 ×
ULN. (Total bilirubin < 3 mg/dL for subjects with Gilbert's disease)
5. Calculated creatinine clearance (CrCl) ≥15 mL/min based on the Cockcroft-Gault
equation
8. Patients of childbearing potential* who are sexually activ partner must use two
methods of effective contraception from screening, and must agree to continue using
such precautions for 23 weeks after the final dose of investigational product:
cessation of birth control after this point should be discussed with a responsible
physician. Periodic abstinence, the rhythm method, and the withdrawal method are not
acceptable methods of birth control.
*Patients of childbearing potential are defined as those who are assigned female at
birth and not surgically sterile (i.e., bilateral tubal ligation, bilateral
oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with
no menses without an alternative medical cause).
9. Male patients who are sexually active with partners of childbearing potential must
use highly effective methods of contraception throughout the study and for at least
four months following the last dose of study treatment. Male patients must agree not
to donate sperm during the study treatment period.
Exclusion Criteria:
1. Uveal melanoma
2. Untreated central nervous system (CNS) metastases or any leptomeningeal involvement.
Asymptomatic brain metastases that have been treated with external radiotherapy are
permitted.
3. Any immunotherapy treatment for unresectable stage III/IV melanoma or any other
prior unresectable malignancy. Prior neoadjuvant and adjuvant ICIs and BRAF/MEK
inhibitors are permitted as long as the last dose was > 6 months prior to
recurrence.
4. Systemic steroid therapy higher than physiologic dose steroid replacement (>10
mg/day of prednisone or equivalent), given within 14 days of starting treatment, or
other immunosuppressive medications within 14 days of the start of treatment.
Inhaled or topical steroids are permitted in the absence of active autoimmune
disease. 5. Treatment with any live/attenuated vaccine within 30 days of first study
treatment. Inactivated and mRNA vaccines are permitted.
6. History of motor neuropathy considered to be of autoimmune origin to be of
autoimmune origin (e.g., Guillain-Barre syndrome, myasthenia gravis) 7. Other
active, concurrent malignancy that requires ongoing systemic treatment or interferes
with radiographic assessment of melanoma response as determined by the investigator
8. History of severe allergic reactions to any unknown allergens or any components
of the study drugs.
9. Uncontrolled (i.e., unstable) concomitant medical condition or organ system
dysfunction which, in the Investigator's opinion, could compromise the patient's
safety or compliance with the study procedures. Participants with type I diabetes
mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as
vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions
not expected to recur in the absence of an external trigger are permitted to enroll.
10. Active hepatitis B virus (HBV) with a viral load >100 IU/mL 11. Active hepatitis
C virus (HCV) with a viral load >100 IU/mL 12. Patients who are breastfeeding or who
are pregnant as evidenced by a positive serum pregnancy test (minimum sensitivity 25
IU/L or equivalent units of HCG) performed within 14 days of the first dose of study
drug.
13. Prisoners or participants who are involuntarily incarcerated. (Note: Under certain
specific circumstances where local regulations permit, a person who has been
imprisoned may be permitted to continue as a participant.) 14. Participants who are
compulsorily detained for treatment of either a psychiatric or physical illness
(e.g., transmissible infection)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hartford Healthcare Alliance (Data Collection Only)
Address:
City:
Hartford
Zip:
06102
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jaykumar Thumar, MD
Phone:
860-676-7000
Facility:
Name:
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Address:
City:
Basking Ridge
Zip:
07920
Country:
United States
Status:
Recruiting
Contact:
Last name:
James Smithy, MD
Phone:
646-888-6782
Facility:
Name:
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Address:
City:
Middletown
Zip:
07748
Country:
United States
Status:
Recruiting
Contact:
Last name:
James Smithy, MD
Phone:
646-888-6782
Facility:
Name:
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Address:
City:
Montvale
Zip:
07645
Country:
United States
Status:
Recruiting
Contact:
Last name:
James Smithy, MD
Phone:
646-888-6782
Facility:
Name:
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Address:
City:
Commack
Zip:
11725
Country:
United States
Status:
Recruiting
Contact:
Last name:
James Smithy, MD
Phone:
646-888-6782
Facility:
Name:
Memorial Sloan Kettering Westchester (All Protocol Activities)
Address:
City:
Harrison
Zip:
10604
Country:
United States
Status:
Recruiting
Contact:
Last name:
James Smithy, MD
Phone:
646-888-6782
Facility:
Name:
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
James Smithy, MD
Phone:
646-888-6782
Facility:
Name:
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Address:
City:
Uniondale
Zip:
11553
Country:
United States
Status:
Recruiting
Contact:
Last name:
James Smithy, MD
Phone:
646-888-6782
Facility:
Name:
Lehigh Valley Health Network (Data Collection Only)
Address:
City:
Allentown
Zip:
18103
Country:
United States
Status:
Recruiting
Contact:
Last name:
Suresh Nair, MD
Phone:
610-402-7880
Start date:
June 9, 2023
Completion date:
June 9, 2027
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Collaborator:
Agency:
IO Biotech
Agency class:
Industry
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05912244
http://www.mskcc.org/mskcc/html/44.cfm
