Squamous Cell Carcinoma of the Head and Neck
Conditions
Brief summary
This study has two, independent, cohorts, both in locally advanced squamous cell head and neck cancer. The purpose of the first cohort is to determine whether nivolumab in combination with radiotherapy is more effective than cetuximab in combination with radiotherapy, in subjects who are ineligible for cisplatin. The purpose of the second cohort is to determine whether nivolumab, cisplatin, and radiotherapy is more effective than cisplatin and radiotherapy in subjects who are eligible to receive cisplatin
Interventions
BIOLOGICALNivolumab
Specified dose on specified day
DRUGCetuximab
Specified dose on specified day
DRUGCisplatin
Specified dose on specified day
RADIATIONRadiotherapy
Specified dose on specified day
Sponsors
Ono Pharmaceutical Co. Ltd
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Histologically proven squamous cell carcinoma of the head and neck (SCCHN) from one of the following primary sites: oral cavity, oropharynx, hypopharynx, and larynx * Locally advanced disease which is unresectable, or resectable but suitable for an organ sparing approach * No previous radiotherapy or systemic treatment for SCCHN
Exclusion criteria
* Carcinoma originating in the nasopharynx or paranasal sinus, squamous cell carcinoma that originated from the skin and salivary gland or non-squamous histology (e.g., mucosal melanoma), squamous cell carcinoma of unknown primary * Clinical or radiological evidence of metastatic disease * Prior radiotherapy that overlaps with radiation fields Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With an Adverse Event (AE) | 30 Days | Number of Participants with an Adverse Event |
| Number of Participants With an Serious Adverse Event (SAE) | 30 days | Number of Participants with an Serious Adverse Event (SAE) |
| Number of Participants With an Adverse Event Leading to Discontinuation | 30 Days | Number of Participants with an Adverse Event Leading to Discontinuation |
| Number of Participants With an Adverse Event Leading to Dose Modification | 30 Days | Number of Participants with an Adverse Event Leading to dose modification |
| Number of Participants With Select Adverse Events | 30 Days | Number of Participants with select adverse events. Select Adverse events include: gastrointestinal, hepatic, hypersensitivity/infusion reaction, pulmonary, renal, or skin. |
| Number of Participants With an Immune-mediated Adverse Event (IMAE) | 100 days | Number of Participants with an immune-mediated adverse event (IMAE) |
| Time to Onset and Time to Resolution of Immune-related Adverse Events | 100 days | Time to onset and time to resolution of immune-related adverse events |
| Number of Participants Who Experienced Death | 100 days | Number of Participants who experienced death |
| Number of Participants With an Abnormality in Specific Thyroid Tests | 30 Days | Number of participants with an abnormality in specific thyroid tests |
| Number of Participants With an Abnormality in Specific Liver Tests | 30 days | Number of participants with an abnormality in specific liver tests |
Countries
France, Italy, Japan, Poland, Russia, South Korea, Spain, Taiwan, Turkey (Türkiye), United States
Participant flow
Pre-assignment details
74 Randomized and 73 treated
Participants by arm
| Arm | Count |
|---|---|
| Arm A (Cohort 1) Nivolumab + Radiotherapy | 12 |
| Arm B (Cohort 1) Cetuximab + Radiotherapy | 10 |
| Arm C (Cohort 2) Cisplatin + Nivolumab + Radiotherapy | 27 |
| Arm D (Cohort 2) Cisplatin + Radiotherapy | 25 |
| Total | 74 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Treatment Period | admin reason by sponsor | 0 | 7 | 0 | 19 |
| Treatment Period | Adverse event unrelated to Study Drug | 2 | 1 | 1 | 1 |
| Treatment Period | completed | 6 | 0 | 18 | 1 |
| Treatment Period | Death | 0 | 0 | 1 | 0 |
| Treatment Period | Disease Progression | 0 | 2 | 0 | 1 |
| Treatment Period | Other Reason | 2 | 0 | 2 | 1 |
| Treatment Period | participant request to discontinue | 0 | 0 | 4 | 0 |
| Treatment Period | participant withdrew consent | 1 | 0 | 0 | 0 |
| Treatment Period | Study Drug Toxicity | 1 | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Arm A (Cohort 1) | Arm B (Cohort 1) | Arm C (Cohort 2) | Arm D (Cohort 2) | Total |
|---|---|---|---|---|---|
| Age, Continuous | 74.5 Years STANDARD_DEVIATION 8.3 | 74.7 Years STANDARD_DEVIATION 6.5 | 59.0 Years STANDARD_DEVIATION 6.6 | 60.8 Years STANDARD_DEVIATION 7 | 64.2 Years STANDARD_DEVIATION 9.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 4 Participants | 9 Participants | 2 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants | 6 Participants | 18 Participants | 23 Participants | 54 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 4 Participants | 6 Participants | 15 Participants | 28 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 3 Participants | 3 Participants | 8 Participants |
| Race (NIH/OMB) White | 8 Participants | 5 Participants | 16 Participants | 7 Participants | 36 Participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 3 Participants | 2 Participants | 9 Participants |
| Sex: Female, Male Male | 10 Participants | 8 Participants | 24 Participants | 23 Participants | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 12 | 2 / 10 | 2 / 27 | 1 / 24 |
| other Total, other adverse events | 12 / 12 | 10 / 10 | 26 / 27 | 24 / 24 |
| serious Total, serious adverse events | 6 / 12 | 5 / 10 | 10 / 27 | 7 / 24 |
Outcome results
Primary
Number of Participants Who Experienced Death
Number of Participants who experienced death
Time frame: 100 days
Population: All Treated Participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A (Cohort 1) | Number of Participants Who Experienced Death | 2 Participants |
| Arm B (Cohort 1) | Number of Participants Who Experienced Death | 2 Participants |
| Arm C (Cohort 2) | Number of Participants Who Experienced Death | 2 Participants |
| Arm D (Cohort 2) | Number of Participants Who Experienced Death | 1 Participants |
Primary
Number of Participants With an Abnormality in Specific Liver Tests
Number of participants with an abnormality in specific liver tests
Time frame: 30 days
Population: All Treated Participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A (Cohort 1) | Number of Participants With an Abnormality in Specific Liver Tests | ALT OR AST > 3XULN | 2 Participants |
| Arm A (Cohort 1) | Number of Participants With an Abnormality in Specific Liver Tests | ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY | 0 Participants |
| Arm A (Cohort 1) | Number of Participants With an Abnormality in Specific Liver Tests | TOTAL BILIRUBIN > 2XULN | 0 Participants |
| Arm A (Cohort 1) | Number of Participants With an Abnormality in Specific Liver Tests | ALT OR AST> 5XULN | 1 Participants |
| Arm A (Cohort 1) | Number of Participants With an Abnormality in Specific Liver Tests | ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30DAYS | 0 Participants |
| Arm A (Cohort 1) | Number of Participants With an Abnormality in Specific Liver Tests | ALT OR AST> 10XULN | 0 Participants |
| Arm A (Cohort 1) | Number of Participants With an Abnormality in Specific Liver Tests | ALT OR AST > 20XULN | 0 Participants |
| Arm B (Cohort 1) | Number of Participants With an Abnormality in Specific Liver Tests | ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY | 0 Participants |
| Arm B (Cohort 1) | Number of Participants With an Abnormality in Specific Liver Tests | ALT OR AST > 20XULN | 0 Participants |
| Arm B (Cohort 1) | Number of Participants With an Abnormality in Specific Liver Tests | ALT OR AST> 10XULN | 0 Participants |
| Arm B (Cohort 1) | Number of Participants With an Abnormality in Specific Liver Tests | TOTAL BILIRUBIN > 2XULN | 0 Participants |
| Arm B (Cohort 1) | Number of Participants With an Abnormality in Specific Liver Tests | ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30DAYS | 0 Participants |
| Arm B (Cohort 1) | Number of Participants With an Abnormality in Specific Liver Tests | ALT OR AST> 5XULN | 0 Participants |
| Arm B (Cohort 1) | Number of Participants With an Abnormality in Specific Liver Tests | ALT OR AST > 3XULN | 0 Participants |
| Arm C (Cohort 2) | Number of Participants With an Abnormality in Specific Liver Tests | ALT OR AST > 20XULN | 0 Participants |
| Arm C (Cohort 2) | Number of Participants With an Abnormality in Specific Liver Tests | ALT OR AST > 3XULN | 0 Participants |
| Arm C (Cohort 2) | Number of Participants With an Abnormality in Specific Liver Tests | ALT OR AST> 5XULN | 0 Participants |
| Arm C (Cohort 2) | Number of Participants With an Abnormality in Specific Liver Tests | ALT OR AST> 10XULN | 0 Participants |
| Arm C (Cohort 2) | Number of Participants With an Abnormality in Specific Liver Tests | TOTAL BILIRUBIN > 2XULN | 0 Participants |
| Arm C (Cohort 2) | Number of Participants With an Abnormality in Specific Liver Tests | ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY | 0 Participants |
| Arm C (Cohort 2) | Number of Participants With an Abnormality in Specific Liver Tests | ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30DAYS | 0 Participants |
| Arm D (Cohort 2) | Number of Participants With an Abnormality in Specific Liver Tests | ALT OR AST> 10XULN | 0 Participants |
| Arm D (Cohort 2) | Number of Participants With an Abnormality in Specific Liver Tests | ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30DAYS | 0 Participants |
| Arm D (Cohort 2) | Number of Participants With an Abnormality in Specific Liver Tests | ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY | 0 Participants |
| Arm D (Cohort 2) | Number of Participants With an Abnormality in Specific Liver Tests | ALT OR AST> 5XULN | 0 Participants |
| Arm D (Cohort 2) | Number of Participants With an Abnormality in Specific Liver Tests | ALT OR AST > 3XULN | 0 Participants |
| Arm D (Cohort 2) | Number of Participants With an Abnormality in Specific Liver Tests | TOTAL BILIRUBIN > 2XULN | 0 Participants |
| Arm D (Cohort 2) | Number of Participants With an Abnormality in Specific Liver Tests | ALT OR AST > 20XULN | 0 Participants |
Primary
Number of Participants With an Abnormality in Specific Thyroid Tests
Number of participants with an abnormality in specific thyroid tests
Time frame: 30 Days
Population: All Treated participants with at least one on-treatment TSH measurement
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A (Cohort 1) | Number of Participants With an Abnormality in Specific Thyroid Tests | TSH > ULN | 5 Participants |
| Arm A (Cohort 1) | Number of Participants With an Abnormality in Specific Thyroid Tests | TSH > ULN WITH TSH <= ULN AT BASELINE | 5 Participants |
| Arm A (Cohort 1) | Number of Participants With an Abnormality in Specific Thyroid Tests | TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN | 4 Participants |
| Arm A (Cohort 1) | Number of Participants With an Abnormality in Specific Thyroid Tests | TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN | 0 Participants |
| Arm A (Cohort 1) | Number of Participants With an Abnormality in Specific Thyroid Tests | TSH > ULN WITH FT3/FT4 TEST MISSING | 1 Participants |
| Arm A (Cohort 1) | Number of Participants With an Abnormality in Specific Thyroid Tests | TSH < LLN | 4 Participants |
| Arm A (Cohort 1) | Number of Participants With an Abnormality in Specific Thyroid Tests | TSH <LLN WITH TSH >= LLN AT BASELINE | 3 Participants |
| Arm A (Cohort 1) | Number of Participants With an Abnormality in Specific Thyroid Tests | TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN | 0 Participants |
| Arm A (Cohort 1) | Number of Participants With an Abnormality in Specific Thyroid Tests | TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN | 4 Participants |
| Arm A (Cohort 1) | Number of Participants With an Abnormality in Specific Thyroid Tests | TSH < LLN WITH FT3/FT4 TEST MISSING | 0 Participants |
| Arm B (Cohort 1) | Number of Participants With an Abnormality in Specific Thyroid Tests | TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN | 0 Participants |
| Arm B (Cohort 1) | Number of Participants With an Abnormality in Specific Thyroid Tests | TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN | 1 Participants |
| Arm B (Cohort 1) | Number of Participants With an Abnormality in Specific Thyroid Tests | TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN | 0 Participants |
| Arm B (Cohort 1) | Number of Participants With an Abnormality in Specific Thyroid Tests | TSH > ULN WITH FT3/FT4 TEST MISSING | 1 Participants |
| Arm B (Cohort 1) | Number of Participants With an Abnormality in Specific Thyroid Tests | TSH < LLN | 3 Participants |
| Arm B (Cohort 1) | Number of Participants With an Abnormality in Specific Thyroid Tests | TSH <LLN WITH TSH >= LLN AT BASELINE | 3 Participants |
| Arm B (Cohort 1) | Number of Participants With an Abnormality in Specific Thyroid Tests | TSH < LLN WITH FT3/FT4 TEST MISSING | 2 Participants |
| Arm B (Cohort 1) | Number of Participants With an Abnormality in Specific Thyroid Tests | TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN | 0 Participants |
| Arm B (Cohort 1) | Number of Participants With an Abnormality in Specific Thyroid Tests | TSH > ULN | 1 Participants |
| Arm B (Cohort 1) | Number of Participants With an Abnormality in Specific Thyroid Tests | TSH > ULN WITH TSH <= ULN AT BASELINE | 1 Participants |
| Arm C (Cohort 2) | Number of Participants With an Abnormality in Specific Thyroid Tests | TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN | 9 Participants |
| Arm C (Cohort 2) | Number of Participants With an Abnormality in Specific Thyroid Tests | TSH <LLN WITH TSH >= LLN AT BASELINE | 13 Participants |
| Arm C (Cohort 2) | Number of Participants With an Abnormality in Specific Thyroid Tests | TSH < LLN WITH FT3/FT4 TEST MISSING | 1 Participants |
| Arm C (Cohort 2) | Number of Participants With an Abnormality in Specific Thyroid Tests | TSH > ULN | 7 Participants |
| Arm C (Cohort 2) | Number of Participants With an Abnormality in Specific Thyroid Tests | TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN | 2 Participants |
| Arm C (Cohort 2) | Number of Participants With an Abnormality in Specific Thyroid Tests | TSH < LLN | 16 Participants |
| Arm C (Cohort 2) | Number of Participants With an Abnormality in Specific Thyroid Tests | TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN | 6 Participants |
| Arm C (Cohort 2) | Number of Participants With an Abnormality in Specific Thyroid Tests | TSH > ULN WITH TSH <= ULN AT BASELINE | 7 Participants |
| Arm C (Cohort 2) | Number of Participants With an Abnormality in Specific Thyroid Tests | TSH > ULN WITH FT3/FT4 TEST MISSING | 1 Participants |
| Arm C (Cohort 2) | Number of Participants With an Abnormality in Specific Thyroid Tests | TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN | 4 Participants |
| Arm D (Cohort 2) | Number of Participants With an Abnormality in Specific Thyroid Tests | TSH > ULN WITH FT3/FT4 TEST MISSING | 0 Participants |
| Arm D (Cohort 2) | Number of Participants With an Abnormality in Specific Thyroid Tests | TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN | 2 Participants |
| Arm D (Cohort 2) | Number of Participants With an Abnormality in Specific Thyroid Tests | TSH < LLN | 13 Participants |
| Arm D (Cohort 2) | Number of Participants With an Abnormality in Specific Thyroid Tests | TSH < LLN WITH FT3/FT4 TEST MISSING | 4 Participants |
| Arm D (Cohort 2) | Number of Participants With an Abnormality in Specific Thyroid Tests | TSH <LLN WITH TSH >= LLN AT BASELINE | 13 Participants |
| Arm D (Cohort 2) | Number of Participants With an Abnormality in Specific Thyroid Tests | TSH > ULN WITH TSH <= ULN AT BASELINE | 1 Participants |
| Arm D (Cohort 2) | Number of Participants With an Abnormality in Specific Thyroid Tests | TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN | 0 Participants |
| Arm D (Cohort 2) | Number of Participants With an Abnormality in Specific Thyroid Tests | TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN | 1 Participants |
| Arm D (Cohort 2) | Number of Participants With an Abnormality in Specific Thyroid Tests | TSH > ULN | 1 Participants |
| Arm D (Cohort 2) | Number of Participants With an Abnormality in Specific Thyroid Tests | TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN | 7 Participants |
Primary
Number of Participants With an Adverse Event (AE)
Number of Participants with an Adverse Event
Time frame: 30 Days
Population: All Treated Participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A (Cohort 1) | Number of Participants With an Adverse Event (AE) | 12 Participants |
| Arm B (Cohort 1) | Number of Participants With an Adverse Event (AE) | 10 Participants |
| Arm C (Cohort 2) | Number of Participants With an Adverse Event (AE) | 27 Participants |
| Arm D (Cohort 2) | Number of Participants With an Adverse Event (AE) | 24 Participants |
Primary
Number of Participants With an Adverse Event Leading to Discontinuation
Number of Participants with an Adverse Event Leading to Discontinuation
Time frame: 30 Days
Population: All Treated Participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A (Cohort 1) | Number of Participants With an Adverse Event Leading to Discontinuation | 2 Participants |
| Arm B (Cohort 1) | Number of Participants With an Adverse Event Leading to Discontinuation | 3 Participants |
| Arm C (Cohort 2) | Number of Participants With an Adverse Event Leading to Discontinuation | 8 Participants |
| Arm D (Cohort 2) | Number of Participants With an Adverse Event Leading to Discontinuation | 4 Participants |
Primary
Number of Participants With an Adverse Event Leading to Dose Modification
Number of Participants with an Adverse Event Leading to dose modification
Time frame: 30 Days
Population: All Treated Participants~Dose levels were maintained, no dose modification occurred
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A (Cohort 1) | Number of Participants With an Adverse Event Leading to Dose Modification | 0 Participants |
| Arm B (Cohort 1) | Number of Participants With an Adverse Event Leading to Dose Modification | 0 Participants |
| Arm C (Cohort 2) | Number of Participants With an Adverse Event Leading to Dose Modification | 0 Participants |
| Arm D (Cohort 2) | Number of Participants With an Adverse Event Leading to Dose Modification | 0 Participants |
Primary
Number of Participants With an Immune-mediated Adverse Event (IMAE)
Number of Participants with an immune-mediated adverse event (IMAE)
Time frame: 100 days
Population: All Treated Participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A (Cohort 1) | Number of Participants With an Immune-mediated Adverse Event (IMAE) | Non-Endocrine related IMAE | 1 Participants |
| Arm A (Cohort 1) | Number of Participants With an Immune-mediated Adverse Event (IMAE) | Endocrine related IMAE | 0 Participants |
| Arm B (Cohort 1) | Number of Participants With an Immune-mediated Adverse Event (IMAE) | Endocrine related IMAE | 0 Participants |
| Arm B (Cohort 1) | Number of Participants With an Immune-mediated Adverse Event (IMAE) | Non-Endocrine related IMAE | 0 Participants |
| Arm C (Cohort 2) | Number of Participants With an Immune-mediated Adverse Event (IMAE) | Non-Endocrine related IMAE | 3 Participants |
| Arm C (Cohort 2) | Number of Participants With an Immune-mediated Adverse Event (IMAE) | Endocrine related IMAE | 4 Participants |
| Arm D (Cohort 2) | Number of Participants With an Immune-mediated Adverse Event (IMAE) | Non-Endocrine related IMAE | 0 Participants |
| Arm D (Cohort 2) | Number of Participants With an Immune-mediated Adverse Event (IMAE) | Endocrine related IMAE | 0 Participants |
Primary
Number of Participants With an Serious Adverse Event (SAE)
Number of Participants with an Serious Adverse Event (SAE)
Time frame: 30 days
Population: All Treated Participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A (Cohort 1) | Number of Participants With an Serious Adverse Event (SAE) | 5 Participants |
| Arm B (Cohort 1) | Number of Participants With an Serious Adverse Event (SAE) | 5 Participants |
| Arm C (Cohort 2) | Number of Participants With an Serious Adverse Event (SAE) | 9 Participants |
| Arm D (Cohort 2) | Number of Participants With an Serious Adverse Event (SAE) | 6 Participants |
Primary
Number of Participants With Select Adverse Events
Number of Participants with select adverse events. Select Adverse events include: gastrointestinal, hepatic, hypersensitivity/infusion reaction, pulmonary, renal, or skin.
Time frame: 30 Days
Population: All Treated Participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A (Cohort 1) | Number of Participants With Select Adverse Events | Gastrointestinal | 4 Participants |
| Arm A (Cohort 1) | Number of Participants With Select Adverse Events | Hepatic | 1 Participants |
| Arm A (Cohort 1) | Number of Participants With Select Adverse Events | Hypersensitivity/Infusion Reaction | 1 Participants |
| Arm A (Cohort 1) | Number of Participants With Select Adverse Events | Pulmonary | 0 Participants |
| Arm A (Cohort 1) | Number of Participants With Select Adverse Events | Renal | 2 Participants |
| Arm A (Cohort 1) | Number of Participants With Select Adverse Events | Skin | 7 Participants |
| Arm B (Cohort 1) | Number of Participants With Select Adverse Events | Skin | 7 Participants |
| Arm B (Cohort 1) | Number of Participants With Select Adverse Events | Pulmonary | 0 Participants |
| Arm B (Cohort 1) | Number of Participants With Select Adverse Events | Gastrointestinal | 3 Participants |
| Arm B (Cohort 1) | Number of Participants With Select Adverse Events | Hypersensitivity/Infusion Reaction | 3 Participants |
| Arm B (Cohort 1) | Number of Participants With Select Adverse Events | Hepatic | 2 Participants |
| Arm B (Cohort 1) | Number of Participants With Select Adverse Events | Renal | 1 Participants |
| Arm C (Cohort 2) | Number of Participants With Select Adverse Events | Hepatic | 2 Participants |
| Arm C (Cohort 2) | Number of Participants With Select Adverse Events | Hypersensitivity/Infusion Reaction | 0 Participants |
| Arm C (Cohort 2) | Number of Participants With Select Adverse Events | Pulmonary | 0 Participants |
| Arm C (Cohort 2) | Number of Participants With Select Adverse Events | Skin | 12 Participants |
| Arm C (Cohort 2) | Number of Participants With Select Adverse Events | Renal | 13 Participants |
| Arm C (Cohort 2) | Number of Participants With Select Adverse Events | Gastrointestinal | 3 Participants |
| Arm D (Cohort 2) | Number of Participants With Select Adverse Events | Renal | 6 Participants |
| Arm D (Cohort 2) | Number of Participants With Select Adverse Events | Skin | 11 Participants |
| Arm D (Cohort 2) | Number of Participants With Select Adverse Events | Hepatic | 3 Participants |
| Arm D (Cohort 2) | Number of Participants With Select Adverse Events | Pulmonary | 0 Participants |
| Arm D (Cohort 2) | Number of Participants With Select Adverse Events | Gastrointestinal | 1 Participants |
| Arm D (Cohort 2) | Number of Participants With Select Adverse Events | Hypersensitivity/Infusion Reaction | 0 Participants |
Primary
Time to Onset and Time to Resolution of Immune-related Adverse Events
Time to onset and time to resolution of immune-related adverse events
Time frame: 100 days
Population: All Treated Participants - Insufficient amount of participants with IMAEs for time to onset and time to resolution
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Time to Onset and Time to Resolution of Immune-related Adverse Events | Endocrine IMAE | — |
| Unknown | Time to Onset and Time to Resolution of Immune-related Adverse Events | Non Endocrine IMAE | — |