This study is researching an investigational drug called marlotamig (REGN7075) by itself and in combination with cemiplimab with or without chemotherapy. The study is focused on patients with certain solid tumors that are in an advanced stage. The aim of the study is to see how safe and tolerable marlotamig is by itself and in combination with cemiplimab (with or without chemotherapy), and to find out what is the best dose of marlotamig to be given to patients with advanced solid tumors when combined with cemiplimab (with or without chemotherapy). Another aim of the study is to see how effective marlotamig by itself, or in combination with cemiplimab (with or without chemotherapy), is at treating cancer patients. The study is also looking at: * Side effects that may be experienced by people taking marlotamig by itself and in combination with cemiplimab with or without chemotherapy * How marlotamig works in the body by itself and in combination with cemiplimab with or without chemotherapy * How much marlotamig is present in the blood when given by itself and in combination with cemiplimab with or without chemotherapy * To see if marlotamig by itself and in combination with cemiplimab with or without chemotherapy works to treat cancer by controlling the proliferation of tumor cells to shrink the tumor * Whether the body makes antibodies against the study drugs (marlotamig and cemiplimab) (which could make the drug less effective or could lead to side effects)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
548
Intravenous (IV) infusion or subcutaneous (SC) injection will be administered every week (QW) or every 3 weeks (Q3W)
Administered concomitantly Q3W by IV infusion or SC injection
Administered IV Q3W
Administered per protocol
Administered per protocol
Valkyrie Clinical Trials
Los Angeles, California, United States
University of California Los Angeles (UCLA) Medical Center
Los Angeles, California, United States
The Regents of the University of California, San Francisco
San Francisco, California, United States
University of Colorado Hospital - Anschutz Cancer Pavilion - Lung Cancer Clinic
Aurora, Colorado, United States
University of Florida Health
Gainesville, Florida, United States
The incidence of Dose-Limiting Toxicities (DLTs) during the DLT period
Dose escalation
Time frame: Up to 6 weeks
Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)
Dose escalation
Time frame: Approximately 90 days from last dose; up to 5 years
Incidence and severity of Adverse Events of Special Interest (AESIs)
Dose escalation
Time frame: Approximately 90 days from last dose; up to 5 years
Incidence and severity of Serious Adverse Events (SAEs)
Dose escalation
Time frame: Approximately 90 days from last dose; up to 5 years
Incidence and severity of grade ≥3 laboratory abnormalities
Dose escalation
Time frame: Approximately 90 days from last dose; up to 5 years
Objective Response Rate (ORR)
Dose expansion
Time frame: Up to 5 years
Concentrations of marlotamig in serum
Dose escalation and dose expansion
Time frame: Up to 5 years
ORR
Dose escalation
Time frame: Up to 5 years
Progression Free Survival (PFS)
Dose escalation and dose expansion
Time frame: Up to 5 years
Duration of Response (DOR)
Dose escalation and dose expansion
Time frame: Up to 5 years
Disease Control Rate (DCR)
Dose escalation and dose expansion
Time frame: Up to 5 years
Complete Response (CR) rate
Dose escalation and dose expansion
Time frame: Up to 5 years
Overall survival (OS)
Dose escalation and dose expansion
Time frame: Up to 5 years
Incidence of Anti-Drug Antibodies (ADA) to marlotamig
Dose escalation and dose expansion
Time frame: Approximately 90 days from last dose; up to 5 years
Magnitude of ADA to marlotamig
Dose escalation and dose expansion
Time frame: Approximately 90 days from last dose; up to 5 years
Incidence of ADA to cemiplimab
Dose escalation and dose expansion
Time frame: Approximately 90 days from last dose; up to 5 years
Magnitude of ADA to cemiplimab
Dose escalation and dose expansion
Time frame: Approximately 90 days from last dose; up to 5 years
The incidence and severity of TEAEs
Dose expansion
Time frame: Approximately 90 days from last dose; up to 5 years
The incidence and severity of AESIs
Dose expansion
Time frame: Approximately 90 days from last dose; up to 5 years
The incidence and severity of SAEs
Dose expansion
Time frame: Approximately 90 days from last dose; up to 5 years
The incidence and severity of grade ≥3 laboratory abnormalities
Dose expansion
Time frame: Approximately 90 days from last dose; up to 5 years
Patient reported Quality of Life (QoL) per European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30
EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including a global health status/quality of life (GHS/QoL) scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.
Time frame: Approximately 90 days from last dose; up to 5 years
Patient reported Quality of Life (QoL) per EORTC QLQ-CR29 in CRC patients
The EORTC QLQ CR-29 questionnaire consists of 29 items (Likert scale), with a response scale for each of them from 1 to 4, with the following structure: 1 = Not at All 2 = A little; 3 = Quite a Bit; 4 = Very much. The QLQ-CR29 has five functional and 18 symptom scales. It contains four subscales (urinary frequency (UF), blood and mucus in stool (BMS), stool frequency (SF), and body image (BI)) and 19 single items (urinary incontinence, dysuria, abdominal pain, buttock pain, bloating, dry mouth, hair loss, taste, anxiety, weight, flatulence, fecal incontinence, sore skin, embarrassment, stoma care problems, sexual interest (men), impotence, sexual interest (women), and dyspareunia). Scores can be linearly transformed to provide a score from 0 to 100. Higher scores represent better functioning on the functional scales and a higher level of symptoms on the symptom scales.
Time frame: Approximately 90 days from last dose; up to 5 years
Patient reported Quality of Life (QoL) per EORTC QLQ-BR23 in breast cancer patients
The EORTC-QLQ-BR23 includes functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions use 4-point Likert scale (1 'Not at All' to 4 'Very Much'). Scores average and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems.
Time frame: Approximately 90 days from last dose; up to 5 years
Patient reported Quality of Life (QoL) per EORTC QLQ-LC13 in NSCLC patients
The EORTC QLQ-LC13 is a 13-item, disease-specific module which assesses quality of life across multiple scales, including dyspnea, cough and chest pain. The scale for EORTC-QLQ-LC13 is 1-4 for most outcome measures of systems, with 1 rated as "not at all" and 4 rated as "very much".
Time frame: Approximately 90 days from last dose; up to 5 years
Patient reported Quality of Life (QoL) per EORTC QLQ-HN35 in HNSCC patients
The EORTC QLQ-HN35 is a 35-item, disease-specific module which assesses quality of life across multiple scales, including pain, swallowing, and senses. The questionnaire has 35 Likert type questions in total and the evaluation is made by giving the score of None: 1, A little: 2, Quite: 3, A lot: 4.
Time frame: Approximately 90 days from last dose; up to 5 years
Patient reported Quality of Life (QoL) per EQ-5D-5L
The EQ-5D-5L consists of EQ-5D descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
Time frame: Approximately 90 days from last dose; up to 5 years
Patient reported symptoms per EORTC QLQ-C30
EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including a global health status/quality of life (GHS/QoL) scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.
Time frame: Approximately 90 days from last dose; up to 5 years
Patient reported symptoms per EORTC QLQ-CR29 in CRC patients
The EORTC QLQ CR-29 questionnaire consists of 29 items (Likert scale), with a response scale for each of them from 1 to 4, with the following structure: 1 = Not at All 2 = A little; 3 = Quite a Bit; 4 = Very much. The QLQ-CR29 has five functional and 18 symptom scales. It contains four subscales (urinary frequency (UF), blood and mucus in stool (BMS), stool frequency (SF), and body image (BI)) and 19 single items (urinary incontinence, dysuria, abdominal pain, buttock pain, bloating, dry mouth, hair loss, taste, anxiety, weight, flatulence, fecal incontinence, sore skin, embarrassment, stoma care problems, sexual interest (men), impotence, sexual interest (women), and dyspareunia). . Scores can be linearly transformed to provide a score from 0 to 100. Higher scores represent better functioning on the functional scales and a higher level of symptoms on the symptom scales.
Time frame: Approximately 90 days from last dose; up to 5 years
Patient reported symptoms per EORTC QLQ-BR23 in breast cancer patients
The EORTC-QLQ-BR23 includes functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions use 4-point Likert scale (1 'Not at All' to 4 'Very Much'). Scores average and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems.
Time frame: Approximately 90 days from last dose; up to 5 years
Patient reported symptoms per EORTC QLQ-LC13 in NSCLC patients
The EORTC QLQ-LC13 is a 13-item, disease-specific module which assesses quality of life across multiple scales, including dyspnea, cough and chest pain. The scale for EORTC-QLQ-LC13 is 1-4 for most outcome measures of systems, with 1 rated as "not at all" and 4 rated as "very much".
Time frame: Approximately 90 days from last dose; up to 5 years
Patient reported symptoms per EORTC QLQ-HN35 in HNSCC patients
The EORTC QLQ-HN35 is a 35-item, disease-specific module which assesses quality of life across multiple scales, including pain, swallowing, and senses. The questionnaire has 35 Likert type questions in total and the evaluation is made by giving the score of None: 1, A little: 2, Quite: 3, A lot: 4.
Time frame: Approximately 90 days from last dose; up to 5 years
Patient reported symptoms per EQ-5D-5L
The EQ-5D-5L consists of EQ-5D descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
Time frame: Approximately 90 days from last dose; up to 5 years
Patient reported functioning per EORTC QLQ-C30
EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including a global health status/quality of life (GHS/QoL) scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.
Time frame: Approximately 90 days from last dose; up to 5 years
Patient reported functioning per EORTC QLQ-CR29 in CRC patients
The EORTC QLQ CR-29 questionnaire consists of 29 items (Likert scale), with a response scale for each of them from 1 to 4, with the following structure: 1 = Not at All 2 = A little; 3 = Quite a Bit; 4 = Very much. The QLQ-CR29 has five functional and 18 symptom scales. It contains four subscales (urinary frequency (UF), blood and mucus in stool (BMS), stool frequency (SF), and body image (BI)) and 19 single items (urinary incontinence, dysuria, abdominal pain, buttock pain, bloating, dry mouth, hair loss, taste, anxiety, weight, flatulence, fecal incontinence, sore skin, embarrassment, stoma care problems, sexual interest (men), impotence, sexual interest (women), and dyspareunia). Scores can be linearly transformed to provide a score from 0 to 100. Higher scores represent better functioning on the functional scales and a higher level of symptoms on the symptom scales.
Time frame: Approximately 90 days from last dose; up to 5 years
Patient reported functioning per EORTC QLQ-BR23 in breast cancer patients
The EORTC-QLQ-BR23 includes functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions use 4-point Likert scale (1 'Not at All' to 4 'Very Much'). Scores average and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems.
Time frame: Approximately 90 days from last dose; up to 5 years
Patient reported functioning per EORTC QLQ-LC13 in NSCLC patients
The EORTC QLQ-LC13 is a 13-item, disease-specific module which assesses quality of life across multiple scales, including dyspnea, cough and chest pain. The scale for EORTC-QLQ-LC13 is 1-4 for most outcome measures of systems, with 1 rated as "not at all" and 4 rated as "very much".
Time frame: Approximately 90 days from last dose; up to 5 years
Patient reported functioning per EORTC QLQ-HN35 in HNSCC patients
The EORTC QLQ-HN35 is a 35-item, disease-specific module which assesses quality of life across multiple scales, including pain, swallowing, and senses. The questionnaire has 35 Likert type questions in total and the evaluation is made by giving the score of None: 1, A little: 2, Quite: 3, A lot: 4.
Time frame: Approximately 90 days from last dose; up to 5 years
Patient reported functioning per EQ-5D-5L
The EQ-5D-5L consists of EQ-5D descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
Time frame: Approximately 90 days from last dose; up to 5 years
Patient reporting general health status per EORTC QLQ-C30
EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including a global health status/quality of life (GHS/QoL) scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.
Time frame: Approximately 90 days from last dose; up to 5 years
Patient reporting general health status per EORTC QLQ-CR29 in CRC patients
The EORTC QLQ CR-29 questionnaire consists of 29 items (Likert scale), with a response scale for each of them from 1 to 4, with the following structure: 1 = Not at All 2 = A little; 3 = Quite a Bit; 4 = Very much. The QLQ-CR29 has five functional and 18 symptom scales. It contains four subscales (urinary frequency (UF), blood and mucus in stool (BMS), stool frequency (SF), and body image (BI)) and 19 single items (urinary incontinence, dysuria, abdominal pain, buttock pain, bloating, dry mouth, hair loss, taste, anxiety, weight, flatulence, fecal incontinence, sore skin, embarrassment, stoma care problems, sexual interest (men), impotence, sexual interest (women), and dyspareunia). Scores can be linearly transformed to provide a score from 0 to 100. Higher scores represent better functioning on the functional scales and a higher level of symptoms on the symptom scales.
Time frame: Approximately 90 days from last dose; up to 5 years
Patient reporting general health status per EORTC QLQ-BR23 in breast cancer patients
The EORTC-QLQ-BR23 includes functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions use 4-point Likert scale (1 'Not at All' to 4 'Very Much'). Scores average and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems.
Time frame: Approximately 90 days from last dose; up to 5 years
Patient reporting general health status per EORTC QLQ-LC13 in NSCLC patients
The EORTC QLQ-LC13 is a 13-item, disease-specific module which assesses quality of life across multiple scales, including dyspnea, cough and chest pain. The scale for EORTC-QLQ-LC13 is 1-4 for most outcome measures of systems, with 1 rated as "not at all" and 4 rated as "very much".
Time frame: Approximately 90 days from last dose; up to 5 years
Patient reporting general health status per EORTC QLQ-HN35 in HNSCC patients
The EORTC QLQ-HN35 is a 35-item, disease-specific module which assesses quality of life across multiple scales, including pain, swallowing, and senses. The questionnaire has 35 Likert type questions in total and the evaluation is made by giving the score of None: 1, A little: 2, Quite: 3, A lot: 4.
Time frame: Approximately 90 days from last dose; up to 5 years
Patient reporting general health status per EQ-5D-5L
The EQ-5D-5L consists of EQ-5D descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
Time frame: Approximately 90 days from last dose; up to 5 years
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