- Drug concentrations of REGN7075 in serum [ Time Frame: Up to 5 years ]
Dose escalation and dose expansion
- Drug concentrations of cemiplimab [ Time Frame: Up to 5 years ]
Dose escalation and dose expansion
- ORR [ Time Frame: Up to 5 years ]
Dose escalation
- Progression free survival (PFS) [ Time Frame: Up to 5 years ]
Dose escalation and dose expansion
- Duration of Response (DOR) [ Time Frame: Up to 5 years ]
Dose escalation and dose expansion
- Disease control rate (DCR) [ Time Frame: Up to 5 years ]
Dose escalation and dose expansion
- Complete response (CR) rate [ Time Frame: Up to 5 years ]
Dose escalation and dose expansion
- Overall survival (OS) [ Time Frame: Up to 5 years ]
Dose escalation and dose expansion
- Incidence of anti-drug antibodies (ADA) to REGN7075 [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
Dose escalation and dose expansion
- Incidence of ADA to cemiplimab [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
Dose escalation and dose expansion
- The incidence and severity of TEAEs [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
Dose expansion
- The incidence and severity of AESIs [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
Dose expansion
- The incidence and severity of SAEs [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
Dose expansion
- The incidence and severity of grade ≥3 laboratory abnormalities [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
Dose expansion
- Patient reported Quality of Life (QoL) per EORTC QLQ-C30 [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
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.
- Patient reported Quality of Life (QoL) per EORTC QLQ-CR29 in CRC patients [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
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.
- Patient reported Quality of Life (QoL) per EORTC QLQ-BR23 in breast cancer patients [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
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 transforme to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems.
- Patient reported Quality of Life (QoL) per EORTC QLQ-LC13 in NSCLC patients [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
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".
- Patient reported Quality of Life (QoL) per EORTC QLQ-HN35 in HNSCC patients [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
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.
- Patient reported Quality of Life (QoL) per EQ-5D-5L [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
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.
- Patient reported symptoms per EORTC QLQ-C30 [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
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.
- Patient reported symptoms per EORTC QLQ-CR29 in CRC patients [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
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.
- Patient reported symptoms per EORTC QLQ-BR23 in breast cancer patients [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
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 transforme to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems.
- Patient reported symptoms per EORTC QLQ-LC13 in NSCLC patients [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
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".
- Patient reported symptoms per EORTC QLQ-HN35 in HNSCC patients [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
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.
- Patient reported symptoms per EQ-5D-5L [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
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.
- Patient reported functioning per EORTC QLQ-C30 [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
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.
- Patient reported functioning per EORTC QLQ-CR29 in CRC patients [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
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.
- Patient reported functioning per EORTC QLQ-BR23 in breast cancer patients [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
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 transforme to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems.
- Patient reported functioning per EORTC QLQ-LC13 in NSCLC patients [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
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".
- Patient reported functioning per EORTC QLQ-HN35 in HNSCC patients [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
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.
- Patient reported functioning per EQ-5D-5L [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
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.
- Patient reporting general health status per EORTC QLQ-C30 [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
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.
- Patient reporting general health status per EORTC QLQ-CR29 in CRC patients [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
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.
- Patient reporting general health status per EORTC QLQ-BR23 in breast cancer patients [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
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 transforme to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems.
- Patient reporting general health status per EORTC QLQ-LC13 in NSCLC patients [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
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".
- Patient reporting general health status per EORTC QLQ-HN35 in HNSCC patients [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
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.
- Patient reporting general health status per EQ-5D-5L [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
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.
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