Uveal Melanoma
Conditions
Keywords
Melanoma, Uveal Cancer, IMCgp100, Immunotherapy, Tebentafusp, Ocular Melanoma, Eye Melanoma, Uveal Melanoma, Gp100, TCR, Dacarbazine, Ipilimumab, Pembrolizumab, Bispecific T cell receptor fusion protein, ImmTAC, Immune mobilizing monoclonal T cell receptor against cancer, Kimmtrak
Brief summary
To evaluate the overall survival of HLA-A\*0201 positive adult patients with previously untreated advanced UM receiving IMCgp100 compared to Investigator's Choice of dacarbazine, ipilimumab, or pembrolizumab.
Detailed description
This Phase II study is designed to evaluate the safety and efficacy of IMCgp100 compared with Investigator's Choice (dacarbazine, ipilimumab or pembrolizumab) in HLA-A\*0201 positive adult patients with advanced UM treated in the first line setting with no prior systemic or liver-directed chemo-, radio- or immune-therapy administered in the advanced setting (prior surgical resection of liver metastases and adjuvant systemic therapy are acceptable). Comparison of the IMCgp100 efficacy results in this Phase II study will be made with the concurrently randomized arm (Investigator's Choice) with a primary endpoint of overall survival (OS) and secondary efficacy endpoints of progression-free survival (PFS), objective response rate (ORR), duration of response (DOR), and disease control rate (DCR).
Interventions
BIOLOGICALIMCgp100
IMCgp100 is to be administered at 20 mcg cycle 1 day1, then 30 mcg cycle 1 day 8, then 68 mcg cycle 1 day 15 and weekly thereafter by IV infusion over 15 minutes until confirmed disease progression or unacceptable toxicity
DRUGDacarbazine
Dacarbazine is to be administered at 1,000 mg/m2 of body surface area IV infusion every 3 weeks until disease progression or unacceptable toxicity
BIOLOGICALIpilimumab
Ipilimumab is to be administered at 3 mg/kg IV infusion over 90 minutes every 3 weeks for a total of 4 treatments
BIOLOGICALPembrolizumab
Pembrolizumab is to be administered at 2 mg/kg IV infusion up to a maximum of 200 mg administered Intravenously over 30 minutes every 3 weeks or 200 mg fixed dose administered intravenously every 3 weeks where approved locally until confirmed disease progression or unacceptable toxicity
Sponsors
Immunocore Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female participants age ≥ 18 years of age at the time of informed consent 2. Ability to provide and understand written informed consent prior to any study procedures 3. Histologically or cytologically confirmed metastatic UM 4. Must meet the following criteria related to prior treatment: * No prior systemic therapy in the metastatic or advanced setting including chemotherapy, immunotherapy, or targeted therapy * No prior regional, liver-directed therapy including chemotherapy, radiotherapy, or embolization * Prior surgical resection of oligometastatic disease is allowed * Prior neoadjuvant or adjuvant therapy is allowed provided administered in the curative setting in participants with localized disease. Participants may not be re-treated with an Investigator's Choice therapy that was administered as adjuvant or neoadjuvant treatment. Additionally, participants who have received nivolumab as prior adjuvant/neoadjuvant treatment should not receive pembrolizumab as Investigator's Choice therapy. 5. HLA A\*0201 positive by central assay 6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 at Screening 7. Participants have measurable disease or non-measurable disease according to RECIST v1.1 8. All other relevant medical conditions must be well-managed and stable, in the opinion of the investigator, for at least 28 days prior to first administration of study drug
Exclusion criteria
1. Out-of-range laboratory values 2. History of severe hypersensitivity reactions (eg, anaphylaxis) to other biologic drugs or monoclonal antibodies 3. Clinically significant cardiac disease or impaired cardiac function, 4. Presence of symptomatic or untreated central nervous system (CNS) metastases, or CNS metastases that require doses of corticosteroids within the prior 3 weeks to study Day 1. Participants with brain metastases are eligible if lesions have been treated with localized therapy and there is no evidence of PD for at least 4 weeks by magnetic resonance imaging (MRI) prior to the first dose of study drug 5. Active infection requiring systemic antibiotic therapy. Participants requiring systemic antibiotics for infection must have completed therapy at least 1 week prior to the first dose of study drug 6. Known history of human immunodeficiency virus infection (HIV). Testing for HIV status is not necessary unless clinically indicated 7. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection per institutional protocol. Testing for HBV or HCV status is not necessary unless clinically indicated or the patient has a history of HBV or HCV infection 8. Malignant disease, other than that being treated in this study. Exceptions to this exclusion include the following: malignancies that were treated curatively and have not recurred within 2 years prior to study treatment; completely resected basal cell and squamous cell skin cancers; any malignancy considered to be indolent and that has never required therapy; and completely resected carcinoma in situ of any type 9. Any medical condition that would, in the investigator's or Sponsor's judgment, prevent the participants participation in the clinical study due to safety concerns, compliance with clinical study procedures or interpretation of study results 10. Participants receiving systemic steroid therapy or any other systemic immunosuppressive medication at any dose level, as these may interfere with the mechanism of action of study treatment. Local steroid therapies (eg, otic, ophthalmic, intra-articular, or inhaled medications) are acceptable 11. History of adrenal insufficiency 12. History of interstitial lung disease 13. History of pneumonitis that required corticosteroid treatment or current pneumonitis 14. History of colitis or inflammatory bowel disease 15. Major surgery within 2 weeks of the first dose of study drug (minimally invasive procedures such as bronchoscopy, tumor biopsy, insertion of a central venous access device, and insertion of a feeding tube are not considered major surgery and are not exclusionary) 16. Radiotherapy within 2 weeks of the first dose of study drug, with the exception of palliative radiotherapy to a limited field, such as for the treatment of bone pain or a focally painful tumor mass 17. Use of hematopoietic colony-stimulating growth factors (e.g., G-CSF, GM-CSF, M-CSF) ≤ 2 weeks prior to start of study drug. An erythroid-stimulating agent is allowed as long as it was initiated at least 2 weeks prior to the first dose of study treatment and the patient is not red blood cell transfusion dependent 18. Pregnant, likely to become pregnant, or lactating women (where pregnancy is defined as the state of a female after conception and until the termination of gestation) 19. Women of childbearing potential who are sexually active with a non-sterilized male partner, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective contraception during study treatment (defined in Section 6.7), and must agree to continue using such precautions for 6 months after the final dose of investigational product; cessation of birth control after this point should be discussed with a responsible physician. Highly effective methods of contraception are described in Section 6.7 20. Male participants must be surgically sterile or use double barrier contraception methods from enrollment through treatment and for 6 months following administration of the last dose of study drug 21. Participant who are in an institution due to official or judicial order. 22. Participant who are the investigator or any subinvestigator, research assistant, pharmacist, study coordinator, or other staff thereof, directly involved in the conduct of the study. 23. Contraindication for treatment with Investigator's Choice alternatives (dacarbazine, ipilimumab and pembrolizumab) as per applicable labelling. Participant may have a contraindication to 1 or 2 of the choices if he/she is a candidate for dosing with at least 1 Investigator's Choice and meets all other study eligibility criteria.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy: Overall Survival | From randomization to the data cut off date of 13-Oct-2020; median follow-up duration was 14.1 months. | Overall survival is defined as the time from randomization to date of death due to any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Number of Participants With Treatment Emergent Adverse Events | Safety was assessed from informed consent through 90 days after end of treatment, up to 36 months. | Safety was defined as the number of participants with treatment emergent adverse events, including laboratory abnormalities, ECG changes, and/or physical examination findings. |
| Efficacy: Progression Free Survival (PFS) | PFS was assessed every 3 months from randomization until disease progression or death, up to 36 months. | Progression free survival (PFS) is defined as the time from randomization to the date of progression (RECIST v1.1) or death due to any cause. |
| Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | EQ-5D,5L was assessed at baseline (Cycle 1 Day 1) and on Day 1 of every other cycle to Cycle 5 Day 1, every fourth cycle thereafter, beginning with Cycle 9 Day 1 and End of Treatment (EOT), up to 36 months. Each cycle is 21 days. | General health status was assessed using the EQ-5D,5L questionnaire, which includes five dimensions (5D): mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 scoring levels, where 1 indicates a better health state (no problems) and 3 indicates a worse health state. A positive change indicates improvement. |
| Quality-of-life: Change From Baseline in EQ-5D Visual Analogue Score (VAS) | EQ-5D,5L VAS was assessed at baseline (Cycle 1 Day 1) and on Day 1 of every other cycle to Cycle 5 Day 1, every fourth cycle thereafter, beginning with Cycle 9 Day 1 and End of Treatment (EOT), up to 36 months. Each cycle is 21 days. | The EQ-5D VAS score records the participant's self-rated health on a vertical visual analogue scale, with 0 being the worst imaginable health state and 100 being the best imaginable health state. A positive change indicates improvement. |
| Quality-of-Life: Change From Baseline in EORTC QLQ-C30 Global Health Status | EORTC QLQ-C30 was assessed at baseline (Cycle 1 Day 1) and on Day 1 of every other cycle to Cycle 5 Day 1, every fourth cycle thereafter, beginning with Cycle 9 Day 1 and End of Treatment (EOT), up to 36 months. Each cycle is 21 days. | Global health status and quality of life was assessed using the EORTC QLQ-C30 questionnaire. The score range for the EORTC QLQ-C30 is from 0 to 100, with higher scores indicating better functioning and better global health status and health-related quality of life. A positive change indicates improvement. |
| Pharmacokinetics (PK): Tebentafusp Concentration | PK concentrations were assessed at pre-dose, end of infusion and anytime in the 12 to 24 hour window after completion of the infusion in Cycle 1 on Days 1, 8 and 15. | Serum PK concentrations of tebentafusp were collected over time. |
| Efficacy: Objective Response Rate (ORR) | ORR will be assessed after every participant has had at least 3 assessments, conducted every 3 months, up to 5.5 years. | Objective response rate (ORR) is defined as the proportion of patients achieving an objective response (RECIST v1.1). |
| Efficacy: Duration of Response (DOR) | DOR will be assessed every 3 months from randomization until disease progression, assessed up to 5.5 years. | Duration of response (DOR) is defined as the time from first documented objective response (RECIST v1.1) until the date of documented disease progression. |
| Efficacy: Disease Control Rate (DCR) | DCR will be assessed every 3 months from randomization until disease progression, up to 5.5 years. | Disease control rate (DCR) is defined as the proportion of patients with either an objective response or stable disease (RECIST v1.1) |
| Pharmacokinetics: Frequency of Anti-IMCgp100 Antibody Formation | Approximately 5 assessments will be performed between first dose of IMCgp100 and end of treatment, assessed up to 5.5 years. | — |
Countries
Australia, Belgium, Canada, France, Germany, Italy, Netherlands, Poland, Russia, Spain, Switzerland, Ukraine, United Kingdom, United States
Contacts
STUDY_DIRECTORImmunocore Medical Information
Immunocore Ltd
Participant flow
Recruitment details
A total of 378 patients were randomly assigned (2:1) to Tebentafusp (n=252) or Investigator's Choice (n=126) at 58 sites in 14 countries.
Pre-assignment details
The data cut-off date for this analysis was 13 October 2020. Combining participants into a single group as part of the Investigator's Choice arm was pre-specified as part of the study design.
Participants by arm
| Arm | Count |
|---|---|
| Tebentafusp Tebentafusp administered at 20 mcg at Cycle 1 Day 1, 30 mcg at Cycle 1 Day 8, and 68 mcg at Cycle 1 Day 15 by IV infusion and weekly thereafter. | 252 |
| Investigator's Choice 1 of 3 Investigator's Choice options: Systemic Dacarbazine, Ipilimumab or Pembrolizumab. Dacarbazine: administered at 1,000 mg/m2 of body surface area IV infusion every 3 weeks until disease progression or unacceptable toxicity; Ipilimumab: administered at 3 mg/kg IV infusion over 90 minutes every 3 weeks for a total of 4 treatments; Pembrolizumab: administered at 2 mg/kg IV infusion up to a maximum of 200 mg administered Intravenously over 30 minutes every 3 weeks or 200 mg fixed dose administered intravenously every 3 weeks where approved locally until confirmed disease progression or unacceptable toxicity. | 126 |
| Total | 378 |
Baseline characteristics
| Characteristic | Tebentafusp | Total | Investigator's Choice |
|---|---|---|---|
| Age, Continuous | 61.3 Years STANDARD_DEVIATION 11.9 | 62.1 Years STANDARD_DEVIATION 11.6 | 63.6 Years STANDARD_DEVIATION 10.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 30 Participants | 48 Participants | 18 Participants |
| Race (NIH/OMB) White | 222 Participants | 329 Participants | 107 Participants |
| Sex: Female, Male Female | 124 Participants | 188 Participants | 64 Participants |
| Sex: Female, Male Male | 128 Participants | 190 Participants | 62 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 84 / 245 | 57 / 111 |
| other Total, other adverse events | 245 / 245 | 102 / 111 |
| serious Total, serious adverse events | 69 / 245 | 26 / 111 |
Outcome results
Primary
Efficacy: Overall Survival
Overall survival is defined as the time from randomization to date of death due to any cause.
Time frame: From randomization to the data cut off date of 13-Oct-2020; median follow-up duration was 14.1 months.
Population: The Intent-to-treat (ITT) Analysis Set comprises all participants assigned to treatment analyzed by the treatment assignment whether or not the participant received the assigned treatment. Combining participants into a single group as part of the Investigator's Choice arm was pre-specified as part of the study design; therefore, data per different treatments were not analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tebentafusp | Efficacy: Overall Survival | 21.7 Months |
| Investigator's Choice | Efficacy: Overall Survival | 16.0 Months |
p-value: <0.000195% CI: [0.37, 0.71]Log Rank
Secondary
Efficacy: Disease Control Rate (DCR)
Disease control rate (DCR) is defined as the proportion of patients with either an objective response or stable disease (RECIST v1.1)
Time frame: DCR will be assessed every 3 months from randomization until disease progression, up to 5.5 years.
Secondary
Efficacy: Duration of Response (DOR)
Duration of response (DOR) is defined as the time from first documented objective response (RECIST v1.1) until the date of documented disease progression.
Time frame: DOR will be assessed every 3 months from randomization until disease progression, assessed up to 5.5 years.
Secondary
Efficacy: Objective Response Rate (ORR)
Objective response rate (ORR) is defined as the proportion of patients achieving an objective response (RECIST v1.1).
Time frame: ORR will be assessed after every participant has had at least 3 assessments, conducted every 3 months, up to 5.5 years.
Secondary
Efficacy: Progression Free Survival (PFS)
Progression free survival (PFS) is defined as the time from randomization to the date of progression (RECIST v1.1) or death due to any cause.
Time frame: PFS was assessed every 3 months from randomization until disease progression or death, up to 36 months.
Population: The Intent-to-treat (ITT) Analysis Set comprises all participants assigned to treatment analyzed by the treatment assignment whether or not the participant received the assigned treatment. Combining participants into a single group as part of the Investigator's Choice arm was pre-specified as part of the study design; therefore, data per different treatments were not analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tebentafusp | Efficacy: Progression Free Survival (PFS) | 3.3 Months |
| Investigator's Choice | Efficacy: Progression Free Survival (PFS) | 2.9 Months |
p-value: 0.013995% CI: [0.58, 0.94]Log Rank
Secondary
Pharmacokinetics: Frequency of Anti-IMCgp100 Antibody Formation
Time frame: Approximately 5 assessments will be performed between first dose of IMCgp100 and end of treatment, assessed up to 5.5 years.
Secondary
Pharmacokinetics (PK): Tebentafusp Concentration
Serum PK concentrations of tebentafusp were collected over time.
Time frame: PK concentrations were assessed at pre-dose, end of infusion and anytime in the 12 to 24 hour window after completion of the infusion in Cycle 1 on Days 1, 8 and 15.
Population: The PK Analysis Set included participants in the Safety Analysis Set who had at least 1 measurable PK concentration and who had relevant date, time, and dosing data for the sample.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Tebentafusp | Pharmacokinetics (PK): Tebentafusp Concentration | Cycle 1 Day 1 - 12 to 24 hours post-infusion | 505.100 pg/mL | Geometric Coefficient of Variation 0.7 |
| Tebentafusp | Pharmacokinetics (PK): Tebentafusp Concentration | Cycle 1 Day 1 - End of Infusion | 4201.929 pg/mL | Geometric Coefficient of Variation 0.6 |
| Tebentafusp | Pharmacokinetics (PK): Tebentafusp Concentration | Cycle 1 Day 8 - End of Infusion | 5787.139 pg/mL | Geometric Coefficient of Variation 0.4 |
| Tebentafusp | Pharmacokinetics (PK): Tebentafusp Concentration | Cycle 1 Day 8 - 12 to 24 hours post-infusion | 738.602 pg/mL | Geometric Coefficient of Variation 0.7 |
| Tebentafusp | Pharmacokinetics (PK): Tebentafusp Concentration | Cycle 1 Day 15 - End of Infusion | 13715.914 pg/mL | Geometric Coefficient of Variation 0.5 |
| Tebentafusp | Pharmacokinetics (PK): Tebentafusp Concentration | Cycle 1 Day 15 - 12 to 24 hours post-infusion | 1685.354 pg/mL | Geometric Coefficient of Variation 0.6 |
Secondary
Quality-of-Life: Change From Baseline in EORTC QLQ-C30 Global Health Status
Global health status and quality of life was assessed using the EORTC QLQ-C30 questionnaire. The score range for the EORTC QLQ-C30 is from 0 to 100, with higher scores indicating better functioning and better global health status and health-related quality of life. A positive change indicates improvement.
Time frame: EORTC QLQ-C30 was assessed at baseline (Cycle 1 Day 1) and on Day 1 of every other cycle to Cycle 5 Day 1, every fourth cycle thereafter, beginning with Cycle 9 Day 1 and End of Treatment (EOT), up to 36 months. Each cycle is 21 days.
Population: The Intent-to-treat (ITT) Analysis Set comprises all participants assigned to treatment analyzed by the treatment assignment whether or not the participant received the assigned treatment. Combining participants into a single group as part of the Investigator's Choice arm was pre-specified as part of the study design; therefore, data per different treatments were not analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tebentafusp | Quality-of-Life: Change From Baseline in EORTC QLQ-C30 Global Health Status | Baseline Cycle 1 | 76.108 Units on a scale | Standard Deviation 20.233 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EORTC QLQ-C30 Global Health Status | Change at Cycle 3 | 0.952 Units on a scale | Standard Deviation 16.274 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EORTC QLQ-C30 Global Health Status | Change at Cycle 5 | -1.152 Units on a scale | Standard Deviation 20.797 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EORTC QLQ-C30 Global Health Status | Change at Cycle 9 | -2.193 Units on a scale | Standard Deviation 19.577 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EORTC QLQ-C30 Global Health Status | Change at Cycle 13 | -5.625 Units on a scale | Standard Deviation 17.641 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EORTC QLQ-C30 Global Health Status | Change at Cycle 17 | -10.185 Units on a scale | Standard Deviation 28.087 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EORTC QLQ-C30 Global Health Status | Change at Cycle 21 | 0.758 Units on a scale | Standard Deviation 18.429 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EORTC QLQ-C30 Global Health Status | Change at Cycle 25 | -2.381 Units on a scale | Standard Deviation 27.936 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EORTC QLQ-C30 Global Health Status | Change at Cycle 29 | -8.333 Units on a scale | Standard Deviation 19.72 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EORTC QLQ-C30 Global Health Status | Change at EOT | -10.417 Units on a scale | Standard Deviation 20.911 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EORTC QLQ-C30 Global Health Status | Change at Cycle 25 | 0.00 Units on a scale | Standard Deviation 0 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EORTC QLQ-C30 Global Health Status | Baseline Cycle 1 | 74.872 Units on a scale | Standard Deviation 20.439 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EORTC QLQ-C30 Global Health Status | Change at Cycle 17 | -4.167 Units on a scale | Standard Deviation 6.972 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EORTC QLQ-C30 Global Health Status | Change at Cycle 3 | -0.238 Units on a scale | Standard Deviation 14.919 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EORTC QLQ-C30 Global Health Status | Change at EOT | -10.539 Units on a scale | Standard Deviation 23.148 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EORTC QLQ-C30 Global Health Status | Change at Cycle 5 | -10.227 Units on a scale | Standard Deviation 22.557 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EORTC QLQ-C30 Global Health Status | Change at Cycle 21 | -4.167 Units on a scale | Standard Deviation 5.893 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EORTC QLQ-C30 Global Health Status | Change at Cycle 9 | -8.333 Units on a scale | Standard Deviation 13.176 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EORTC QLQ-C30 Global Health Status | Change at Cycle 29 | 0.00 Units on a scale | Standard Deviation 0 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EORTC QLQ-C30 Global Health Status | Change at Cycle 13 | -10.185 Units on a scale | Standard Deviation 16.017 |
Secondary
Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores
General health status was assessed using the EQ-5D,5L questionnaire, which includes five dimensions (5D): mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 scoring levels, where 1 indicates a better health state (no problems) and 3 indicates a worse health state. A positive change indicates improvement.
Time frame: EQ-5D,5L was assessed at baseline (Cycle 1 Day 1) and on Day 1 of every other cycle to Cycle 5 Day 1, every fourth cycle thereafter, beginning with Cycle 9 Day 1 and End of Treatment (EOT), up to 36 months. Each cycle is 21 days.
Population: The Intent-to-treat (ITT) Analysis Set comprises all participants assigned to treatment analyzed by the treatment assignment whether or not the participant received the assigned treatment. Combining participants into a single group as part of the Investigator's Choice arm was pre-specified as part of the study design; therefore, data per different treatments were not analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tebentafusp | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Self-care - Change at Cycle 3 | 0.0 Units on a scale | Standard Deviation 0.49 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Mobility - Baseline Cycle 1 | 1.2 Units on a scale | Standard Deviation 0.62 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Mobility - Change at Cycle 3 | -0.1 Units on a scale | Standard Deviation 0.66 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Mobility - Change at Cycle 5 | 0.0 Units on a scale | Standard Deviation 0.73 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Mobility - Change at Cycle 9 | 0.0 Units on a scale | Standard Deviation 0.91 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Mobility - Change at Cycle 13 | -0.1 Units on a scale | Standard Deviation 0.6 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Mobility - Change at Cycle 17 | 0.3 Units on a scale | Standard Deviation 0.57 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Mobility - Change at Cycle 21 | 0.0 Units on a scale | Standard Deviation 0.58 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Mobility - Change at Cycle 25 | 0.1 Units on a scale | Standard Deviation 0.64 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Mobility - Change at Cycle 29 | 0.0 Units on a scale | Standard Deviation 0.5 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Mobility - Change at EOT | 0.3 Units on a scale | Standard Deviation 0.73 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Self-care - Baseline Cycle 1 | 1.1 Units on a scale | Standard Deviation 0.45 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Usual activities - Baseline Cycle 1 | 1.2 Units on a scale | Standard Deviation 0.53 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Self-care - Change at Cycle 5 | 0.0 Units on a scale | Standard Deviation 0.42 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Self-care - Change at Cycle 9 | 0.0 Units on a scale | Standard Deviation 0.58 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Self-care - Change at Cycle 13 | 0.1 Units on a scale | Standard Deviation 0.52 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Self-care - Change at Cycle 17 | 0.1 Units on a scale | Standard Deviation 0.68 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Self-care - Change at Cycle 21 | 0.0 Units on a scale | Standard Deviation 0 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Self-care - Change at Cycle 25 | 0.0 Units on a scale | Standard Deviation 0 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Self-care - Change at Cycle 29 | 0.0 Units on a scale | Standard Deviation 0 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Self-care - Change at EOT | 0.1 Units on a scale | Standard Deviation 0.6 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Usual activities - Change at Cycle 3 | 0.2 Units on a scale | Standard Deviation 0.59 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Usual activities - Change at Cycle 5 | 0.1 Units on a scale | Standard Deviation 0.61 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Usual activities - Change at Cycle 9 | 0.2 Units on a scale | Standard Deviation 0.87 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Usual activities - Change at Cycle 13 | 0.3 Units on a scale | Standard Deviation 0.79 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Usual activities - Change at Cycle 17 | 0.5 Units on a scale | Standard Deviation 0.8 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Usual activities - Change at Cycle 21 | 0.3 Units on a scale | Standard Deviation 0.48 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Usual activities - Change at Cycle 25 | 0.3 Units on a scale | Standard Deviation 0.46 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Usual activities - Change at Cycle 29 | 0.2 Units on a scale | Standard Deviation 0.44 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Usual activities - Change at EOT | 0.4 Units on a scale | Standard Deviation 0.77 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Pain/Discomfort - Baseline Cycle 1 | 1.5 Units on a scale | Standard Deviation 0.71 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Pain/Discomfort - Change at Cycle 3 | 0.0 Units on a scale | Standard Deviation 0.75 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Pain/Discomfort - Change at Cycle 5 | 0.0 Units on a scale | Standard Deviation 0.65 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Pain/Discomfort - Change at Cycle 9 | 0.1 Units on a scale | Standard Deviation 0.73 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Pain/Discomfort - Change at Cycle 13 | 0.1 Units on a scale | Standard Deviation 0.51 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Pain/Discomfort - Change at Cycle 17 | 0.4 Units on a scale | Standard Deviation 0.85 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Pain/Discomfort - Change at Cycle 21 | 0.2 Units on a scale | Standard Deviation 0.55 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Pain/Discomfort - Change at Cycle 25 | 0.0 Units on a scale | Standard Deviation 0.53 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Pain/Discomfort - Change at Cycle 29 | 0.1 Units on a scale | Standard Deviation 0.6 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Pain/Discomfort - Change at EOT | 0.2 Units on a scale | Standard Deviation 0.87 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Anxiety/Depression - Baseline Cycle 1 | 1.8 Units on a scale | Standard Deviation 0.94 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Anxiety/Depression - Change at Cycle 3 | -0.2 Units on a scale | Standard Deviation 0.77 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Anxiety/Depression - Change at Cycle 5 | -0.2 Units on a scale | Standard Deviation 0.74 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Anxiety/Depression - Change at Cycle 9 | -0.3 Units on a scale | Standard Deviation 0.8 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Anxiety/Depression - Change at Cycle 13 | -0.4 Units on a scale | Standard Deviation 0.77 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Anxiety/Depression - Change at Cycle 17 | -0.4 Units on a scale | Standard Deviation 0.85 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Anxiety/Depression - Change at Cycle 21 | -0.5 Units on a scale | Standard Deviation 0.88 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Anxiety/Depression - Change at Cycle 25 | -0.4 Units on a scale | Standard Deviation 0.74 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Anxiety/Depression - Change at Cycle 29 | -0.6 Units on a scale | Standard Deviation 0.88 |
| Tebentafusp | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Anxiety/Depression - Change at EOT | 0.3 Units on a scale | Standard Deviation 0.94 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Pain/Discomfort - Change at Cycle 25 | 1.0 Units on a scale | — |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Usual activities - Baseline Cycle 1 | 1.3 Units on a scale | Standard Deviation 0.55 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Usual activities - Change at Cycle 17 | 0.2 Units on a scale | Standard Deviation 0.41 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Mobility - Baseline Cycle 1 | 1.3 Units on a scale | Standard Deviation 0.55 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Anxiety/Depression - Change at Cycle 29 | 0.5 Units on a scale | Standard Deviation 0.71 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Mobility - Change at Cycle 3 | 0.1 Units on a scale | Standard Deviation 0.47 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Usual activities - Change at Cycle 21 | 0.0 Units on a scale | Standard Deviation 0 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Mobility - Change at Cycle 5 | 0.3 Units on a scale | Standard Deviation 0.65 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Pain/Discomfort - Change at Cycle 29 | 0.5 Units on a scale | Standard Deviation 0.71 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Mobility - Change at Cycle 9 | 0.0 Units on a scale | Standard Deviation 0.55 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Usual activities - Change at Cycle 25 | 0.0 Units on a scale | Standard Deviation 0 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Mobility - Change at Cycle 13 | 0.3 Units on a scale | Standard Deviation 0.87 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Anxiety/Depression - Change at Cycle 13 | -0.1 Units on a scale | Standard Deviation 0.6 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Mobility - Change at Cycle 17 | 0.2 Units on a scale | Standard Deviation 0.41 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Usual activities - Change at Cycle 29 | 0.0 Units on a scale | Standard Deviation 0 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Mobility - Change at Cycle 21 | 0.5 Units on a scale | Standard Deviation 0.71 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Pain/Discomfort - Change at EOT | 0.4 Units on a scale | Standard Deviation 1.1 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Mobility - Change at Cycle 25 | 0.0 Units on a scale | Standard Deviation 0 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Usual activities - Change at EOT | 0.5 Units on a scale | Standard Deviation 0.87 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Mobility - Change at Cycle 29 | 0.0 Units on a scale | Standard Deviation 0 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Pain/Discomfort - Change at Cycle 21 | 0.0 Units on a scale | Standard Deviation 0 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Mobility - Change at EOT | 0.4 Units on a scale | Standard Deviation 0.99 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Anxiety/Depression - Change at Cycle 25 | 0.0 Units on a scale | — |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Self-care - Baseline Cycle 1 | 1.1 Units on a scale | Standard Deviation 0.29 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Pain/Discomfort - Baseline Cycle 1 | 1.5 Units on a scale | Standard Deviation 0.73 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Self-care - Change at Cycle 3 | 0.0 Units on a scale | Standard Deviation 0.26 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Anxiety/Depression - Baseline Cycle 1 | 1.7 Units on a scale | Standard Deviation 0.89 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Self-care - Change at Cycle 5 | 0.0 Units on a scale | Standard Deviation 0 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Pain/Discomfort - Change at Cycle 3 | 0.1 Units on a scale | Standard Deviation 0.73 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Self-care - Change at Cycle 9 | 0.0 Units on a scale | Standard Deviation 0 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Anxiety/Depression - Change at Cycle 17 | 0.0 Units on a scale | Standard Deviation 0 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Self-care - Change at Cycle 13 | 0.1 Units on a scale | Standard Deviation 0.33 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Pain/Discomfort - Change at Cycle 5 | 0.2 Units on a scale | Standard Deviation 0.72 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Self-care - Change at Cycle 17 | 0.0 Units on a scale | Standard Deviation 0 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Anxiety/Depression - Change at Cycle 3 | -0.3 Units on a scale | Standard Deviation 0.55 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Self-care - Change at Cycle 21 | 0.0 Units on a scale | Standard Deviation 0 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Pain/Discomfort - Change at Cycle 9 | -0.1 Units on a scale | Standard Deviation 0.73 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Self-care - Change at Cycle 25 | 0.0 Units on a scale | Standard Deviation 0 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Anxiety/Depression - Change at EOT | 0.2 Units on a scale | Standard Deviation 1.07 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Self-care - Change at Cycle 29 | 0.0 Units on a scale | Standard Deviation 0 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Pain/Discomfort - Change at Cycle 13 | 0.1 Units on a scale | Standard Deviation 0.93 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Self-care - Change at EOT | 0.1 Units on a scale | Standard Deviation 0.56 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Anxiety/Depression - Change at Cycle 5 | 0.0 Units on a scale | Standard Deviation 0.61 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Usual activities - Change at Cycle 3 | 0.1 Units on a scale | Standard Deviation 0.73 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Pain/Discomfort - Change at Cycle 17 | 0.3 Units on a scale | Standard Deviation 0.52 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Usual activities - Change at Cycle 5 | 0.2 Units on a scale | Standard Deviation 0.61 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Anxiety/Depression - Change at Cycle 21 | 0.0 Units on a scale | Standard Deviation 0 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Usual activities - Change at Cycle 9 | 0.1 Units on a scale | Standard Deviation 0.53 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Anxiety/Depression - Change at Cycle 9 | 0.1 Units on a scale | Standard Deviation 0.77 |
| Investigator's Choice | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Usual activities - Change at Cycle 13 | 0.1 Units on a scale | Standard Deviation 0.6 |
Secondary
Quality-of-life: Change From Baseline in EQ-5D Visual Analogue Score (VAS)
The EQ-5D VAS score records the participant's self-rated health on a vertical visual analogue scale, with 0 being the worst imaginable health state and 100 being the best imaginable health state. A positive change indicates improvement.
Time frame: EQ-5D,5L VAS was assessed at baseline (Cycle 1 Day 1) and on Day 1 of every other cycle to Cycle 5 Day 1, every fourth cycle thereafter, beginning with Cycle 9 Day 1 and End of Treatment (EOT), up to 36 months. Each cycle is 21 days.
Population: The Intent-to-treat (ITT) Analysis Set comprises all participants assigned to treatment analyzed by the treatment assignment whether or not the participant received the assigned treatment. Combining participants into a single group as part of the Investigator's Choice arm was pre-specified as part of the study design; therefore, data per different treatments were not analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tebentafusp | Quality-of-life: Change From Baseline in EQ-5D Visual Analogue Score (VAS) | Baseline Cycle 1 | 81.0 Units on a scale | Standard Deviation 16.36 |
| Tebentafusp | Quality-of-life: Change From Baseline in EQ-5D Visual Analogue Score (VAS) | Change at Cycle 3 | 0.4 Units on a scale | Standard Deviation 14.69 |
| Tebentafusp | Quality-of-life: Change From Baseline in EQ-5D Visual Analogue Score (VAS) | Change at Cycle 5 | 0.6 Units on a scale | Standard Deviation 15.61 |
| Tebentafusp | Quality-of-life: Change From Baseline in EQ-5D Visual Analogue Score (VAS) | Change at Cycle 9 | -0.9 Units on a scale | Standard Deviation 19.81 |
| Tebentafusp | Quality-of-life: Change From Baseline in EQ-5D Visual Analogue Score (VAS) | Change at Cycle 13 | -2.0 Units on a scale | Standard Deviation 16.48 |
| Tebentafusp | Quality-of-life: Change From Baseline in EQ-5D Visual Analogue Score (VAS) | Change at Cycle 17 | -10.2 Units on a scale | Standard Deviation 20.93 |
| Tebentafusp | Quality-of-life: Change From Baseline in EQ-5D Visual Analogue Score (VAS) | Change at Cycle 21 | -1.8 Units on a scale | Standard Deviation 14.52 |
| Tebentafusp | Quality-of-life: Change From Baseline in EQ-5D Visual Analogue Score (VAS) | Change at Cycle 25 | -13.6 Units on a scale | Standard Deviation 19.43 |
| Tebentafusp | Quality-of-life: Change From Baseline in EQ-5D Visual Analogue Score (VAS) | Change at Cycle 29 | 0.0 Units on a scale | Standard Deviation 9.25 |
| Tebentafusp | Quality-of-life: Change From Baseline in EQ-5D Visual Analogue Score (VAS) | Change at EOT | -10.1 Units on a scale | Standard Deviation 22.53 |
| Investigator's Choice | Quality-of-life: Change From Baseline in EQ-5D Visual Analogue Score (VAS) | Change at Cycle 25 | -4.0 Units on a scale | — |
| Investigator's Choice | Quality-of-life: Change From Baseline in EQ-5D Visual Analogue Score (VAS) | Baseline Cycle 1 | 80.4 Units on a scale | Standard Deviation 18.31 |
| Investigator's Choice | Quality-of-life: Change From Baseline in EQ-5D Visual Analogue Score (VAS) | Change at Cycle 17 | -8.5 Units on a scale | Standard Deviation 33.82 |
| Investigator's Choice | Quality-of-life: Change From Baseline in EQ-5D Visual Analogue Score (VAS) | Change at Cycle 3 | -0.8 Units on a scale | Standard Deviation 14.28 |
| Investigator's Choice | Quality-of-life: Change From Baseline in EQ-5D Visual Analogue Score (VAS) | Change at EOT | -11.7 Units on a scale | Standard Deviation 21.4 |
| Investigator's Choice | Quality-of-life: Change From Baseline in EQ-5D Visual Analogue Score (VAS) | Change at Cycle 5 | -0.7 Units on a scale | Standard Deviation 14.38 |
| Investigator's Choice | Quality-of-life: Change From Baseline in EQ-5D Visual Analogue Score (VAS) | Change at Cycle 21 | -1.0 Units on a scale | Standard Deviation 5.66 |
| Investigator's Choice | Quality-of-life: Change From Baseline in EQ-5D Visual Analogue Score (VAS) | Change at Cycle 9 | -3.3 Units on a scale | Standard Deviation 13.3 |
| Investigator's Choice | Quality-of-life: Change From Baseline in EQ-5D Visual Analogue Score (VAS) | Change at Cycle 29 | -2.0 Units on a scale | Standard Deviation 1.41 |
| Investigator's Choice | Quality-of-life: Change From Baseline in EQ-5D Visual Analogue Score (VAS) | Change at Cycle 13 | -2.6 Units on a scale | Standard Deviation 8.37 |
Secondary
Safety: Number of Participants With Treatment Emergent Adverse Events
Safety was defined as the number of participants with treatment emergent adverse events, including laboratory abnormalities, ECG changes, and/or physical examination findings.
Time frame: Safety was assessed from informed consent through 90 days after end of treatment, up to 36 months.
Population: The Safety Analysis Set includes all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group as part of the Investigator's Choice arm was pre-specified as part of the study design; therefore, data per different treatments were not analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tebentafusp | Safety: Number of Participants With Treatment Emergent Adverse Events | 245 Participants |
| Investigator's Choice | Safety: Number of Participants With Treatment Emergent Adverse Events | 105 Participants |