Trial Outcomes & Findings for Testing the Addition of the Anti-cancer Viral Therapy Telomelysin™ to Chemoradiation for Patients With Advanced Esophageal Cancer and Are Not Candidates for Surgery (NCT NCT04391049)

Last Updated: 2026-01-30

Results Overview

Adverse events are graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, which grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. A DLT is defined as the following that are definitely or probably attributed to OBP-301: * Any grade ≥3 adverse event EXCEPT for the following: * Grade 3 nausea/vomiting * Grade 3 esophagitis or dehydration * The first occurrence of grade 3/4 neutropenia * Grade 3/4 lymphopenia (since this is a known toxicity of chemoradiation and OBP-301) * Any toxicity that leads to a \>14-day cumulative delay in chemoradiation. If 0 or 1 participants of 6 participants experienced a DLT, then the treatment regimen would be considered safe (and 9 more would be accrued for secondary endpoints). Otherwise, the regimen would be deemed too toxic and a second cohort of six participants would be accrued to a lower dose of OBP-301 (1 x 10\^11 vp/mL).

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE1

Target enrollment

16 participants

Primary outcome timeframe

From start of protocol treatment until 30 days after the completion of chemoradiation, approximately 10 weeks.

Results posted on

2026-01-30

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (OBP-301, Carboplatin, Paclitaxel, Radiation) Patients receive OBP-301 (1×10\^12 vp/mL) by intra-tumoral injection via endoscopy on days -3, 12, and 26. Patients also receive paclitaxel IV (50 mg/m\^2) over 60 minutes followed by carboplatin IV (AUC 2) over 30 minutes and on days 1, 8, 15, 22, and 29, and undergo radiation therapy (1.8 Gy/faction) on Monday through Friday beginning day 1 for 28 fractions (50.4 Gy total) over 5.5 weeks. All treatment continues in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	16
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (OBP-301, Carboplatin, Paclitaxel, Radiation) Patients receive OBP-301 (1×10\^12 vp/mL) by intra-tumoral injection via endoscopy on days -3, 12, and 26. Patients also receive paclitaxel IV (50 mg/m\^2) over 60 minutes followed by carboplatin IV (AUC 2) over 30 minutes and on days 1, 8, 15, 22, and 29, and undergo radiation therapy (1.8 Gy/faction) on Monday through Friday beginning day 1 for 28 fractions (50.4 Gy total) over 5.5 weeks. All treatment continues in the absence of disease progression or unacceptable toxicity.
Overall Study Protocol Violation	1

Baseline Characteristics

Participants with tumor location of esophagogastric junction.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (OBP-301, Carboplatin, Paclitaxel, Radiation) n=15 Participants Patients receive OBP-301 (1×10\^12 vp/mL) by intra-tumoral injection via endoscopy on days -3, 12, and 26. Patients also receive paclitaxel IV (50 mg/m\^2) over 60 minutes followed by carboplatin IV (AUC 2) over 30 minutes and on days 1, 8, 15, 22, and 29, and undergo radiation therapy (1.8 Gy/faction) on Monday through Friday beginning day 1 for 28 fractions (50.4 Gy total) over 5.5 weeks. All treatment continues in the absence of disease progression or unacceptable toxicity.
Age, Continuous	74 years n=15 Participants
Sex: Female, Male Female	3 Participants n=15 Participants
Sex: Female, Male Male	12 Participants n=15 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=15 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=15 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=15 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=15 Participants
Race (NIH/OMB) Asian	0 Participants n=15 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=15 Participants
Race (NIH/OMB) Black or African American	0 Participants n=15 Participants
Race (NIH/OMB) White	15 Participants n=15 Participants
Race (NIH/OMB) More than one race	0 Participants n=15 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=15 Participants
Zubrod Performance Status 0 (Asymptomatic)	6 Participants n=15 Participants
Zubrod Performance Status 1 (Symptomatic but completely ambulatory)	9 Participants n=15 Participants
Histologic Type Adenocarcinoma	11 Participants n=15 Participants
Histologic Type Squamous cell carcinoma	4 Participants n=15 Participants
Tumor Location Esophagogastric junction	3 Participants n=15 Participants
Tumor Location Esophagus	12 Participants n=15 Participants
Siewert Type for Esophagogastric Junction Type I	2 Participants n=3 Participants • Participants with tumor location of esophagogastric junction.
Siewert Type for Esophagogastric Junction Type II	1 Participants n=3 Participants • Participants with tumor location of esophagogastric junction.
Clinical T Category T1b (Tumor has invaded the submucosa, but not penetrated the muscularis propria.)	2 Participants n=15 Participants
Clinical T Category T2 (Tumor invades the muscularis propria.)	4 Participants n=15 Participants
Clinical T Category T3 (Tumor invades the adventitia.)	9 Participants n=15 Participants
Clinical N Category N0 (No regional lymph nodes)	3 Participants n=15 Participants
Clinical N Category N1 (1-2 regional lymph nodes)	7 Participants n=15 Participants
Clinical N Category N2 (3-6 regional lymph nodes)	2 Participants n=15 Participants
Clinical N Category N3 (7 or more regional lymph nodes)	2 Participants n=15 Participants
Clinical N Category NX (Regional lymph nodes cannot be assessed or evaluated)	1 Participants n=15 Participants
Extent of Dysphagia Asymptomatic	5 Participants n=15 Participants
Extent of Dysphagia Symptomatic, unrestricted diet	5 Participants n=15 Participants
Extent of Dysphagia Symptomatic, soft foods only	4 Participants n=15 Participants
Extent of Dysphagia Symptomatic, liquids only	1 Participants n=15 Participants

PRIMARY outcome

Timeframe: From start of protocol treatment until 30 days after the completion of chemoradiation, approximately 10 weeks.

Population: First six eligible participants who started all protocol treatment and either experienced a DLT in the evaluation period or completed the evaluation period without a DLT.

Outcome measures

Outcome measures
Measure	Treatment (OBP-301, Carboplatin, Paclitaxel, Radiation) n=6 Participants Patients receive OBP-301 (1×10\^12 vp/mL) by intra-tumoral injection via endoscopy on days -3, 12, and 26. Patients also receive paclitaxel IV (50 mg/m\^2) over 60 minutes followed by carboplatin IV (AUC 2) over 30 minutes and on days 1, 8, 15, 22, and 29, and undergo radiation therapy (1.8 Gy/faction) on Monday through Friday beginning day 1 for 28 fractions (50.4 Gy total) over 5.5 weeks. All treatment continues in the absence of disease progression or unacceptable toxicity.
Number of Participants Experiencing Any Dose-Limiting Toxicities (DLTs)	0 Participants

SECONDARY outcome

Timeframe: From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months.

Population: Eligible participants who started treatment

The Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.

Outcome measures

Outcome measures
Measure	Treatment (OBP-301, Carboplatin, Paclitaxel, Radiation) n=15 Participants Patients receive OBP-301 (1×10\^12 vp/mL) by intra-tumoral injection via endoscopy on days -3, 12, and 26. Patients also receive paclitaxel IV (50 mg/m\^2) over 60 minutes followed by carboplatin IV (AUC 2) over 30 minutes and on days 1, 8, 15, 22, and 29, and undergo radiation therapy (1.8 Gy/faction) on Monday through Friday beginning day 1 for 28 fractions (50.4 Gy total) over 5.5 weeks. All treatment continues in the absence of disease progression or unacceptable toxicity.
Number of Participants by Highest Grade Adverse Event Reported Definitely or probably related to OBP-301 protocol treatment · Grade 4	1 Participants
Number of Participants by Highest Grade Adverse Event Reported Definitely or probably related to OBP-301 protocol treatment · Grade 5	0 Participants
Number of Participants by Highest Grade Adverse Event Reported All adverse events · Grade 1	1 Participants
Number of Participants by Highest Grade Adverse Event Reported All adverse events · None reported	0 Participants
Number of Participants by Highest Grade Adverse Event Reported All adverse events · Grade 2	1 Participants
Number of Participants by Highest Grade Adverse Event Reported All adverse events · Grade 3	7 Participants
Number of Participants by Highest Grade Adverse Event Reported All adverse events · Grade 4	4 Participants
Number of Participants by Highest Grade Adverse Event Reported All adverse events · Grade 5	2 Participants
Number of Participants by Highest Grade Adverse Event Reported Definitely or probably related to any protocol treatment · None reported	1 Participants
Number of Participants by Highest Grade Adverse Event Reported Definitely or probably related to any protocol treatment · Grade 1	3 Participants
Number of Participants by Highest Grade Adverse Event Reported Definitely or probably related to any protocol treatment · Grade 2	1 Participants
Number of Participants by Highest Grade Adverse Event Reported Definitely or probably related to any protocol treatment · Grade 3	8 Participants
Number of Participants by Highest Grade Adverse Event Reported Definitely or probably related to any protocol treatment · Grade 4	1 Participants
Number of Participants by Highest Grade Adverse Event Reported Definitely or probably related to any protocol treatment · Grade 5	1 Participants
Number of Participants by Highest Grade Adverse Event Reported Definitely or probably related to OBP-301 protocol treatment · None reported	7 Participants
Number of Participants by Highest Grade Adverse Event Reported Definitely or probably related to OBP-301 protocol treatment · Grade 1	2 Participants
Number of Participants by Highest Grade Adverse Event Reported Definitely or probably related to OBP-301 protocol treatment · Grade 2	5 Participants
Number of Participants by Highest Grade Adverse Event Reported Definitely or probably related to OBP-301 protocol treatment · Grade 3	0 Participants

SECONDARY outcome

Timeframe: 6-8 weeks after completion of chemoradiation, approximately 11.5-13.5 weeks from baseline.

Population: Eligible and started protocol treatment.

Clinical complete response is defined as grossly free of disease as determined by a visual inspection or if the visual inspection was not certain, then a negative biopsy. The number of participants is determined for two populations: * Complete case analysis only includes eligible participants who started protocol treatment and were assessed for cCR; * Sensitivity analysis includes all eligible participants who started protocol treatment and counts participants without an assessment as not achieving a cCR.

Outcome measures

Outcome measures
Measure	Treatment (OBP-301, Carboplatin, Paclitaxel, Radiation) n=15 Participants Patients receive OBP-301 (1×10\^12 vp/mL) by intra-tumoral injection via endoscopy on days -3, 12, and 26. Patients also receive paclitaxel IV (50 mg/m\^2) over 60 minutes followed by carboplatin IV (AUC 2) over 30 minutes and on days 1, 8, 15, 22, and 29, and undergo radiation therapy (1.8 Gy/faction) on Monday through Friday beginning day 1 for 28 fractions (50.4 Gy total) over 5.5 weeks. All treatment continues in the absence of disease progression or unacceptable toxicity.
Number of Participants With Clinical Complete Response (cCR) Complete Case Analysis	13 Participants
Number of Participants With Clinical Complete Response (cCR) Sensitivity Analysis	13 Participants

SECONDARY outcome

Timeframe: At 1 and 2 years

Progression is defined as pathologically confirmed recurrence of local disease or clinical evidence of distant disease.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 1 and 2 years

Outcome measures

Outcome data not reported

Adverse Events

Treatment (OBP-301, Carboplatin, Paclitaxel, Radiation)

Serious events: 7 serious events

Other events: 15 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (OBP-301, Carboplatin, Paclitaxel, Radiation) n=15 participants at risk Patients receive OBP-301 (1×10\^12 vp/mL) by intra-tumoral injection via endoscopy on days -3, 12, and 26. Patients also receive paclitaxel IV (50 mg/m\^2) over 60 minutes followed by carboplatin IV (AUC 2) over 30 minutes and on days 1, 8, 15, 22, and 29, and undergo radiation therapy (1.8 Gy/faction) on Monday through Friday beginning day 1 for 28 fractions (50.4 Gy total) over 5.5 weeks. All treatment continues in the absence of disease progression or unacceptable toxicity.
Cardiac disorders Atrial fibrillation	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Gastrointestinal disorders Esophageal fistula	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Gastrointestinal disorders Esophageal stenosis	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
General disorders Fever	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Infections and infestations Lung infection	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Infections and infestations Sepsis	13.3% 2/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Injury, poisoning and procedural complications Fall	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Investigations Neutrophil count decreased	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Metabolism and nutrition disorders Dehydration	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Respiratory, thoracic and mediastinal disorders Respiratory failure	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.

Other adverse events

Other adverse events
Measure	Treatment (OBP-301, Carboplatin, Paclitaxel, Radiation) n=15 participants at risk Patients receive OBP-301 (1×10\^12 vp/mL) by intra-tumoral injection via endoscopy on days -3, 12, and 26. Patients also receive paclitaxel IV (50 mg/m\^2) over 60 minutes followed by carboplatin IV (AUC 2) over 30 minutes and on days 1, 8, 15, 22, and 29, and undergo radiation therapy (1.8 Gy/faction) on Monday through Friday beginning day 1 for 28 fractions (50.4 Gy total) over 5.5 weeks. All treatment continues in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Anemia	66.7% 10/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Blood and lymphatic system disorders Eosinophilia	13.3% 2/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Cardiac disorders Sinus tachycardia	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Ear and labyrinth disorders Ear pain	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Gastrointestinal disorders Abdominal pain	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Gastrointestinal disorders Belching	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Gastrointestinal disorders Constipation	60.0% 9/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Gastrointestinal disorders Diarrhea	53.3% 8/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Gastrointestinal disorders Dyspepsia	13.3% 2/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Gastrointestinal disorders Dysphagia	20.0% 3/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Gastrointestinal disorders Esophageal hemorrhage	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Gastrointestinal disorders Esophageal pain	33.3% 5/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Gastrointestinal disorders Esophageal ulcer	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Gastrointestinal disorders Esophagitis	33.3% 5/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Gastrointestinal disorders Flatulence	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Gastrointestinal disorders Gastritis	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Gastrointestinal disorders Gastroesophageal reflux disease	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Gastrointestinal disorders Gastrointestinal disorders - Other	13.3% 2/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Gastrointestinal disorders Gastrointestinal pain	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Gastrointestinal disorders Mucositis oral	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Gastrointestinal disorders Nausea	60.0% 9/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Gastrointestinal disorders Vomiting	20.0% 3/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
General disorders Chills	33.3% 5/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
General disorders Edema limbs	20.0% 3/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
General disorders Fatigue	86.7% 13/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
General disorders Fever	26.7% 4/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
General disorders Flu like symptoms	13.3% 2/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
General disorders Gait disturbance	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
General disorders General disorders and administration site conditions - Other	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
General disorders Injection site reaction	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
General disorders Localized edema	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
General disorders Malaise	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
General disorders Non-cardiac chest pain	13.3% 2/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Infections and infestations Esophageal infection	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Infections and infestations Infections and infestations - Other	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Infections and infestations Lung infection	13.3% 2/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Infections and infestations Sepsis	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Infections and infestations Vaginal infection	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Injury, poisoning and procedural complications Dermatitis radiation	20.0% 3/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Injury, poisoning and procedural complications Fall	13.3% 2/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Injury, poisoning and procedural complications Infusion related reaction	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Investigations Alanine aminotransferase increased	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Investigations Alkaline phosphatase increased	13.3% 2/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Investigations Aspartate aminotransferase increased	13.3% 2/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Investigations Blood bilirubin increased	13.3% 2/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Investigations Blood lactate dehydrogenase increased	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Investigations Creatinine increased	13.3% 2/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Investigations Investigations - Other	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Investigations Lymphocyte count decreased	80.0% 12/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Investigations Neutrophil count decreased	60.0% 9/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Investigations Platelet count decreased	53.3% 8/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Investigations Thyroid stimulating hormone increased	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Investigations Weight gain	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Investigations Weight loss	13.3% 2/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Investigations White blood cell decreased	80.0% 12/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Metabolism and nutrition disorders Anorexia	46.7% 7/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Metabolism and nutrition disorders Dehydration	13.3% 2/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Metabolism and nutrition disorders Hypercalcemia	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Metabolism and nutrition disorders Hyperglycemia	26.7% 4/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Metabolism and nutrition disorders Hyperkalemia	13.3% 2/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Metabolism and nutrition disorders Hypernatremia	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Metabolism and nutrition disorders Hypoalbuminemia	46.7% 7/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Metabolism and nutrition disorders Hypocalcemia	26.7% 4/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Metabolism and nutrition disorders Hypokalemia	20.0% 3/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Metabolism and nutrition disorders Hypomagnesemia	20.0% 3/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Metabolism and nutrition disorders Hyponatremia	53.3% 8/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Musculoskeletal and connective tissue disorders Arthralgia	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Musculoskeletal and connective tissue disorders Back pain	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Musculoskeletal and connective tissue disorders Myalgia	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Musculoskeletal and connective tissue disorders Neck pain	13.3% 2/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	13.3% 2/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Nervous system disorders Dizziness	20.0% 3/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Nervous system disorders Dysgeusia	13.3% 2/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Nervous system disorders Dysphasia	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Nervous system disorders Headache	33.3% 5/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Nervous system disorders Peripheral motor neuropathy	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Nervous system disorders Peripheral sensory neuropathy	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Nervous system disorders Syncope	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Nervous system disorders Tremor	13.3% 2/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Psychiatric disorders Anxiety	20.0% 3/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Psychiatric disorders Depression	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Psychiatric disorders Insomnia	20.0% 3/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Renal and urinary disorders Chronic kidney disease	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Renal and urinary disorders Glucosuria	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Renal and urinary disorders Urinary urgency	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Reproductive system and breast disorders Erectile dysfunction	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Respiratory, thoracic and mediastinal disorders Atelectasis	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Respiratory, thoracic and mediastinal disorders Cough	26.7% 4/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	20.0% 3/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	13.3% 2/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Respiratory, thoracic and mediastinal disorders Hiccups	20.0% 3/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	13.3% 2/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Respiratory, thoracic and mediastinal disorders Productive cough	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Respiratory, thoracic and mediastinal disorders Sore throat	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Skin and subcutaneous tissue disorders Alopecia	20.0% 3/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Skin and subcutaneous tissue disorders Hyperhidrosis	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Skin and subcutaneous tissue disorders Pruritus	13.3% 2/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Skin and subcutaneous tissue disorders Rash maculo-papular	13.3% 2/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Vascular disorders Flushing	13.3% 2/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Vascular disorders Hot flashes	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Vascular disorders Hypertension	13.3% 2/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Vascular disorders Hypotension	26.7% 4/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Vascular disorders Thromboembolic event	13.3% 2/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.
Vascular disorders Vascular disorders - Other	6.7% 1/15 • From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months. All-cause mortality and adverse events were assessed in eligible participants who started protocol treatment.

Additional Information

Wendy Seiferheld

NRG Oncology

Phone: 215-574-3208

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
Publication restrictions are in place

Restriction type: OTHER