Trial Outcomes & Findings for MSB0010445 and Stereotactic Body Radiation Therapy in Advanced Melanoma (NCT NCT01973608)

NCT ID: NCT01973608

Last Updated: 2016-10-31

Results Overview

DLT was defined as any Grade\>= 3 toxicity related to drug, occurring during 21 days post first dose of drug except Grade 3 infusion-related adverse reaction resolving within 6 hours and Transient (\<=6 hours) Grade 3 flu-like symptoms/fever controlled with medical management; Transient (\<= 24 hours) Grade 3 fatigue, local reactions, headache, nausea, emesis that resolved to \<= Grade 1; Grade 3 skin toxicity ,Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \< 8 x upper limit of normal (ULN)/total bilirubin \< 5 x ULN resolving to \<= Grade 1 in \<7 days after medical management; Grade 3 diarrhea controlled with maximal medical management within 72 hours; Grade 4 lymphopenia that resolves to \<= Grade 1 within 7 days \& with no clinical manifestations; Grade 3 lab abnormality with no clinical correlation and resolves to \<= Grade 1 within 7 days with adequate medical management Tumor flare defined as local pain, irritation or rash localized at sites of known/suspected tumor.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

12 participants

Primary outcome timeframe

Baseline up to Day 21

Results posted on

2016-10-31

Participant Flow

First/Last subject (informed consent): 24 January 2014/17 December 2014. Study completion date:10 June 2015. The study was conducted at 6 sites in the United States.

Participant milestones

Participant milestones
Measure	MSB0010445 Low Dose Cohort 0.3 mg/kg MSB0010445 was administered at a single dose of 0.3 mg/kg as intravenous (IV) infusion over approximately 1 hour every 3 weeks (q3w) for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of Stereotactic Body Radiation Therapy (SBRT) to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions if one site was targeted subject received 3 fractions (1 per day) of 8 Gray (Gy) each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).	MSB0010445 Intermediate Dose Cohort 1.0 mg/kg MSB0010445 was administered at a single dose of 1.0 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).	MSB0010445 High Dose Cohort 1.8 mg/kg MSB0010445 was administered at a single dose of 1.8 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).	MSB0010445 High Dose Cohort 2.4 mg/kg MSB0010445 was administered at a single dose of 2.4 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
Overall Study STARTED	2	2	6	2
Overall Study COMPLETED	2	2	6	2
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

MSB0010445 and Stereotactic Body Radiation Therapy in Advanced Melanoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MSB0010445 Low Dose Cohort 0.3 mg/kg n=2 Participants MSB0010445 was administered at a dose of 0.3 mg/kg as IV infusion over approximately 1 hour q3w until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. One site was targeted and was received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose was 18 Gy (3 x 6 Gy).	MSB0010445 Intermediate Dose Cohort 1.0 mg/kg n=2 Participants MSB0010445 was administered at a dose of 1.0 mg/kg as IV infusion over approximately 1 hour q3w until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. One site was targeted and was received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose was 18 Gy (3 x 6 Gy).	MSB0010445 High Dose Cohort 1.8 mg/kg n=6 Participants MSB0010445 was administered at a dose of 1.8 mg/kg as IV infusion over approximately 1 hour q3w until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. One site was targeted and was received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose was 18 Gy (3 x 6 Gy).	MSB0010445 High Dose Cohort 2.4 mg/kg n=2 Participants MSB0010445 was administered at a dose of 2.4 mg/kg as IV infusion over approximately 1 hour q3w until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. One site was targeted and was received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose was 18 Gy (3 x 6 Gy).	Total n=12 Participants Total of all reporting groups
Age, Continuous	55.12 years STANDARD_DEVIATION 13.48 • n=5 Participants	59.55 years STANDARD_DEVIATION 4.11 • n=7 Participants	59.67 years STANDARD_DEVIATION 6.29 • n=5 Participants	53.78 years STANDARD_DEVIATION 20.03 • n=4 Participants	57.91 years STANDARD_DEVIATION 8.90 • n=21 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	5 Participants n=21 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	1 Participants n=4 Participants	7 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline up to Day 21

Population: Safety analysis set included all subjects who signed informed consent, were enrolled into the study and received at least 1 dose of MSB0010445.

Outcome measures

Outcome measures
Measure	MSB0010445 Low Dose Cohort 0.3 mg/kg n=2 Participants MSB0010445 was administered at a single dose of 0.3 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).	MSB0010445 Intermediate Dose Cohort 1.0 mg/kg n=2 Participants MSB0010445 was administered at a single dose of 1.0 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).	MSB0010445 High Dose Cohort 1.8 mg/kg n=6 Participants MSB0010445 was administered at a single dose of 1.8 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).	MSB0010445 High Dose Cohort 2.4 mg/kg n=2 Participants MSB0010445 was administered at a single dose of 2.4 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
Number of Subjects With at Least 1 Dose Limiting Toxicity (DLT)	0 subjects	0 subjects	1 subjects	0 subjects

SECONDARY outcome

Timeframe: Screening up to 28 days after last dose of drug; assessed up to maximum of 1.41 years

Population: Safety analysis set included all subjects who signed informed consent, were enrolled into the study and received at least 1 dose of MSB0010445. Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure.

BOR was defined as a confirmed complete response (CR) or partial response (PR) during second-line treatment. For target lesions (TLs), CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD. For non-target lesions (NTLs), CR was defined as the disappearance of all NTLs and normalization of tumor marker levels.

Outcome measures

Outcome measures
Measure	MSB0010445 Low Dose Cohort 0.3 mg/kg n=2 Participants MSB0010445 was administered at a single dose of 0.3 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).	MSB0010445 Intermediate Dose Cohort 1.0 mg/kg n=1 Participants MSB0010445 was administered at a single dose of 1.0 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).	MSB0010445 High Dose Cohort 1.8 mg/kg n=4 Participants MSB0010445 was administered at a single dose of 1.8 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).	MSB0010445 High Dose Cohort 2.4 mg/kg n=1 Participants MSB0010445 was administered at a single dose of 2.4 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
Number of Subjects With Best Overall Response (BOR) According to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 CR	0 subjects	0 subjects	0 subjects	0 subjects
Number of Subjects With Best Overall Response (BOR) According to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 PR	0 subjects	0 subjects	0 subjects	0 subjects

SECONDARY outcome

Timeframe: Screening up to 28 days after last dose of drug; assessed up to maximum of 1.41 years

Population: Safety analysis set included all subjects who signed informed consent, were enrolled into the study and received at least 1 dose of MSB0010445.

TEAE was defined as an AE that started on or after the first administration of SBRT. An SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/ significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.

Outcome measures

Outcome measures
Measure	MSB0010445 Low Dose Cohort 0.3 mg/kg n=2 Participants MSB0010445 was administered at a single dose of 0.3 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).	MSB0010445 Intermediate Dose Cohort 1.0 mg/kg n=2 Participants MSB0010445 was administered at a single dose of 1.0 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).	MSB0010445 High Dose Cohort 1.8 mg/kg n=6 Participants MSB0010445 was administered at a single dose of 1.8 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).	MSB0010445 High Dose Cohort 2.4 mg/kg n=2 Participants MSB0010445 was administered at a single dose of 2.4 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
Number of Subjects With Treatment-Emergent Adverse Events (AEs) or Serious AEs Treatment Emergent Adverse Events	2 subjects	2 subjects	6 subjects	2 subjects
Number of Subjects With Treatment-Emergent Adverse Events (AEs) or Serious AEs Serious AEs	0 subjects	0 subjects	3 subjects	1 subjects

Adverse Events

MSB0010445 Low Dose Cohort 0.3 mg/kg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

MSB0010445 Intermediate Dose Cohort 1.0 mg/kg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

MSB0010445 High Dose Cohort 1.8 mg/kg

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

MSB0010445 High Dose Cohort 2.4 mg/kg

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MSB0010445 Low Dose Cohort 0.3 mg/kg n=2 participants at risk MSB0010445 was administered at a single dose of 0.3 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).	MSB0010445 Intermediate Dose Cohort 1.0 mg/kg n=2 participants at risk MSB0010445 was administered at a single dose of 1.0 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).	MSB0010445 High Dose Cohort 1.8 mg/kg n=6 participants at risk MSB0010445 was administered at a single dose of 1.8 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).	MSB0010445 High Dose Cohort 2.4 mg/kg n=2 participants at risk MSB0010445 was administered at a single dose of 2.4 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
Gastrointestinal disorders Nausea	0.00% 0/2 • Signing of the informed consent up to 1.41 years	0.00% 0/2 • Signing of the informed consent up to 1.41 years	16.7% 1/6 • Signing of the informed consent up to 1.41 years	0.00% 0/2 • Signing of the informed consent up to 1.41 years
Gastrointestinal disorders Vomiting	0.00% 0/2 • Signing of the informed consent up to 1.41 years	0.00% 0/2 • Signing of the informed consent up to 1.41 years	16.7% 1/6 • Signing of the informed consent up to 1.41 years	0.00% 0/2 • Signing of the informed consent up to 1.41 years
General disorders Non-cardiac chest pain	0.00% 0/2 • Signing of the informed consent up to 1.41 years	0.00% 0/2 • Signing of the informed consent up to 1.41 years	16.7% 1/6 • Signing of the informed consent up to 1.41 years	0.00% 0/2 • Signing of the informed consent up to 1.41 years
Infections and infestations Pneumonia	0.00% 0/2 • Signing of the informed consent up to 1.41 years	0.00% 0/2 • Signing of the informed consent up to 1.41 years	16.7% 1/6 • Signing of the informed consent up to 1.41 years	0.00% 0/2 • Signing of the informed consent up to 1.41 years
Metabolism and nutrition disorders Dehydration	0.00% 0/2 • Signing of the informed consent up to 1.41 years	0.00% 0/2 • Signing of the informed consent up to 1.41 years	16.7% 1/6 • Signing of the informed consent up to 1.41 years	0.00% 0/2 • Signing of the informed consent up to 1.41 years
Gastrointestinal disorders Dysphagia	0.00% 0/2 • Signing of the informed consent up to 1.41 years	0.00% 0/2 • Signing of the informed consent up to 1.41 years	16.7% 1/6 • Signing of the informed consent up to 1.41 years	0.00% 0/2 • Signing of the informed consent up to 1.41 years
General disorders Disease progression	0.00% 0/2 • Signing of the informed consent up to 1.41 years	0.00% 0/2 • Signing of the informed consent up to 1.41 years	16.7% 1/6 • Signing of the informed consent up to 1.41 years	0.00% 0/2 • Signing of the informed consent up to 1.41 years
Cardiac disorders Cardiomyopathy	0.00% 0/2 • Signing of the informed consent up to 1.41 years	0.00% 0/2 • Signing of the informed consent up to 1.41 years	0.00% 0/6 • Signing of the informed consent up to 1.41 years	50.0% 1/2 • Signing of the informed consent up to 1.41 years

Other adverse events

Additional Information

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Principal investigator is a sponsor employee
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