Trial Outcomes & Findings for Pilot Study With CY, Pembrolizumab, GVAX, and IMC-CS4 (LY3022855) in Patients With Borderline Resectable Adenocarcinoma of the Pancreas (NCT NCT03153410)

Last Updated: 2025-01-09

Results Overview

Treatment-related immunologic effect is defined as an 80% or greater increase in the number of CD8+ T cells (and at least 1.8 times the baseline median absolute deviation) in surgically resected tumor tissue in comparison to the baseline biopsy in subjects that received at least 1 dose of neoadjuvant combination immunotherapy and underwent a R0, R1, or R2 surgical resection.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

11 participants

Primary outcome timeframe

8 weeks

Results posted on

2025-01-09

Participant Flow

2 participants were excluded from analysis because they did not receive the study drug.

Participant milestones

Participant milestones
Measure	Cyclophosphamide, GVAX, Pembrolizumab and IMC-CS4 Cyclophosphamide: 200 mg/m\^2, intravenous (IV) infusion GVAX: 5x10\^8 cells, six intradermal (ID) injections Pembrolizumab: 200 mg, intravenous (IV) infusion IMC-CS4: 75 mg (dose level 1) or 100 mg (dose level 2), intravenous (IV) infusion Patients receive neoadjuvant immunotherapy consisting of cyclophosphamide and pembrolizumab on day 1, IMC-CS4 on days 1, 8, and 15, and GVAX on day 2 of Cycles 1 and 2 (3 weeks/cycle). Patients will then undergo pancreaticoduodenectomy 2-3 weeks later, followed by standard of care adjuvant chemotherapy at the discretion of the primary oncologist. Patients may then receive 4 cycles (3 weeks/cycle) of adjuvant immunotherapy (same regimen as Cycles 1 and 2). Disease free patients may receive an additional 12 booster cycles (3 weeks/cycle) of immunotherapy consisting of pembrolizumab on day 1 of all 12 booster cycles, as well as cyclophosphamide on day 1 and GVAX on day 2 of the 6th and 12th booster cycle.
Overall Study STARTED	9
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Study With CY, Pembrolizumab, GVAX, and IMC-CS4 (LY3022855) in Patients With Borderline Resectable Adenocarcinoma of the Pancreas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cyclophosphamide, GVAX, Pembrolizumab and IMC-CS4 n=9 Participants Cyclophosphamide: 200 mg/m\^2, intravenous (IV) infusion GVAX: 5x10\^8 cells, six intradermal (ID) injections Pembrolizumab: 200 mg, intravenous (IV) infusion IMC-CS4: 75 mg (dose level 1) or 100 mg (dose level 2), intravenous (IV) infusion Patients receive neoadjuvant immunotherapy consisting of cyclophosphamide and pembrolizumab on day 1, IMC-CS4 on days 1, 8, and 15, and GVAX on day 2 of Cycles 1 and 2 (3 weeks/cycle). Patients will then undergo pancreaticoduodenectomy 2-3 weeks later, followed by standard of care adjuvant chemotherapy at the discretion of the primary oncologist. Patients may then receive 4 cycles (3 weeks/cycle) of adjuvant immunotherapy (same regimen as Cycles 1 and 2). Disease free patients may receive an additional 12 booster cycles (3 weeks/cycle) of immunotherapy consisting of pembrolizumab on day 1 of all 12 booster cycles, as well as cyclophosphamide on day 1 and GVAX on day 2 of the 6th and 12th booster cycle.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: 8/9 patients were included in the analysis because obtaining pre-treatment biopsy was not possible in one patient.

Outcome measures

Outcome measures
Measure	Cyclophosphamide, GVAX, Pembrolizumab and IMC-CS4 n=8 Participants Cyclophosphamide: 200 mg/m\^2, intravenous (IV) infusion GVAX: 5x10\^8 cells, six intradermal (ID) injections Pembrolizumab: 200 mg, intravenous (IV) infusion IMC-CS4: 75 mg (dose level 1) or 100 mg (dose level 2), intravenous (IV) infusion Patients receive neoadjuvant immunotherapy consisting of cyclophosphamide and pembrolizumab on day 1, IMC-CS4 on days 1, 8, and 15, and GVAX on day 2 of Cycles 1 and 2 (3 weeks/cycle). Patients will then undergo pancreaticoduodenectomy 2-3 weeks later, followed by standard of care adjuvant chemotherapy at the discretion of the primary oncologist. Patients may then receive 4 cycles (3 weeks/cycle) of adjuvant immunotherapy (same regimen as Cycles 1 and 2). Disease free patients may receive an additional 12 booster cycles (3 weeks/cycle) of immunotherapy consisting of pembrolizumab on day 1 of all 12 booster cycles, as well as cyclophosphamide on day 1 and GVAX on day 2 of the 6th and 12th booster cycle.
Number of Patients With a Treatment-related Immunologic Effect	6 Participants

PRIMARY outcome

Timeframe: 25 months

Number of subjects that experienced a grade 3 or higher study drug related adverse event

Outcome measures

Outcome measures
Measure	Cyclophosphamide, GVAX, Pembrolizumab and IMC-CS4 n=9 Participants Cyclophosphamide: 200 mg/m\^2, intravenous (IV) infusion GVAX: 5x10\^8 cells, six intradermal (ID) injections Pembrolizumab: 200 mg, intravenous (IV) infusion IMC-CS4: 75 mg (dose level 1) or 100 mg (dose level 2), intravenous (IV) infusion Patients receive neoadjuvant immunotherapy consisting of cyclophosphamide and pembrolizumab on day 1, IMC-CS4 on days 1, 8, and 15, and GVAX on day 2 of Cycles 1 and 2 (3 weeks/cycle). Patients will then undergo pancreaticoduodenectomy 2-3 weeks later, followed by standard of care adjuvant chemotherapy at the discretion of the primary oncologist. Patients may then receive 4 cycles (3 weeks/cycle) of adjuvant immunotherapy (same regimen as Cycles 1 and 2). Disease free patients may receive an additional 12 booster cycles (3 weeks/cycle) of immunotherapy consisting of pembrolizumab on day 1 of all 12 booster cycles, as well as cyclophosphamide on day 1 and GVAX on day 2 of the 6th and 12th booster cycle.
Safety of the Combination of GVAX Pancreas Vaccine (With CY), Pembrolizumab, and a Macrophage Targeting Agent (CSF1R Inhibitor IMC-CS4) in Patients With Resectable or Borderline Resectable Pancreatic Cancer (BRPC) Prior to and Following Surgery	2 Participants

SECONDARY outcome

Timeframe: 44 months

OS will be measured from date of first dose until death or end of follow-up (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve.

Outcome measures

Outcome measures
Measure	Cyclophosphamide, GVAX, Pembrolizumab and IMC-CS4 n=9 Participants Cyclophosphamide: 200 mg/m\^2, intravenous (IV) infusion GVAX: 5x10\^8 cells, six intradermal (ID) injections Pembrolizumab: 200 mg, intravenous (IV) infusion IMC-CS4: 75 mg (dose level 1) or 100 mg (dose level 2), intravenous (IV) infusion Patients receive neoadjuvant immunotherapy consisting of cyclophosphamide and pembrolizumab on day 1, IMC-CS4 on days 1, 8, and 15, and GVAX on day 2 of Cycles 1 and 2 (3 weeks/cycle). Patients will then undergo pancreaticoduodenectomy 2-3 weeks later, followed by standard of care adjuvant chemotherapy at the discretion of the primary oncologist. Patients may then receive 4 cycles (3 weeks/cycle) of adjuvant immunotherapy (same regimen as Cycles 1 and 2). Disease free patients may receive an additional 12 booster cycles (3 weeks/cycle) of immunotherapy consisting of pembrolizumab on day 1 of all 12 booster cycles, as well as cyclophosphamide on day 1 and GVAX on day 2 of the 6th and 12th booster cycle.
Overall Survival (OS)	20.4 months Interval 17.5 to NA Explanation: Upper bound confidence interval was not estimable due to insufficient number of events

SECONDARY outcome

Timeframe: 37 months

DFS is defined as time from fist dose of study drug to the date of progression or death. Subjects were censored at the date of last scan if alive at the time of analyses or if the subject's date of death was greater than 3 months after last scan. Estimation based on the Kaplan-Meier curve.

Outcome measures

Outcome measures
Measure	Cyclophosphamide, GVAX, Pembrolizumab and IMC-CS4 n=9 Participants Cyclophosphamide: 200 mg/m\^2, intravenous (IV) infusion GVAX: 5x10\^8 cells, six intradermal (ID) injections Pembrolizumab: 200 mg, intravenous (IV) infusion IMC-CS4: 75 mg (dose level 1) or 100 mg (dose level 2), intravenous (IV) infusion Patients receive neoadjuvant immunotherapy consisting of cyclophosphamide and pembrolizumab on day 1, IMC-CS4 on days 1, 8, and 15, and GVAX on day 2 of Cycles 1 and 2 (3 weeks/cycle). Patients will then undergo pancreaticoduodenectomy 2-3 weeks later, followed by standard of care adjuvant chemotherapy at the discretion of the primary oncologist. Patients may then receive 4 cycles (3 weeks/cycle) of adjuvant immunotherapy (same regimen as Cycles 1 and 2). Disease free patients may receive an additional 12 booster cycles (3 weeks/cycle) of immunotherapy consisting of pembrolizumab on day 1 of all 12 booster cycles, as well as cyclophosphamide on day 1 and GVAX on day 2 of the 6th and 12th booster cycle.
Disease Free Survival (DFS)	12.6 months Interval 7.3 to NA Explanation: Upper bound confidence interval was not estimable due to insufficient number of events

SECONDARY outcome

Timeframe: Up to 10 weeks from baseline irRC read

Population: 7/9 patients were evaluable for assessment by irRC criteria

Immune-related Objective Response Rate (irORR) is defined as the number of patients achieving a complete response (irCR) or partial response (irPR) based on immune related response criteria (irRC) following the study immunotherapy prior to surgical resection. Per irRC criteria, Complete Response (irCR) is the disappearance of all target lesions, Partial Response (irPR) is a decrease in tumor burden by 50% or greater.

Outcome measures

Outcome measures
Measure	Cyclophosphamide, GVAX, Pembrolizumab and IMC-CS4 n=7 Participants Cyclophosphamide: 200 mg/m\^2, intravenous (IV) infusion GVAX: 5x10\^8 cells, six intradermal (ID) injections Pembrolizumab: 200 mg, intravenous (IV) infusion IMC-CS4: 75 mg (dose level 1) or 100 mg (dose level 2), intravenous (IV) infusion Patients receive neoadjuvant immunotherapy consisting of cyclophosphamide and pembrolizumab on day 1, IMC-CS4 on days 1, 8, and 15, and GVAX on day 2 of Cycles 1 and 2 (3 weeks/cycle). Patients will then undergo pancreaticoduodenectomy 2-3 weeks later, followed by standard of care adjuvant chemotherapy at the discretion of the primary oncologist. Patients may then receive 4 cycles (3 weeks/cycle) of adjuvant immunotherapy (same regimen as Cycles 1 and 2). Disease free patients may receive an additional 12 booster cycles (3 weeks/cycle) of immunotherapy consisting of pembrolizumab on day 1 of all 12 booster cycles, as well as cyclophosphamide on day 1 and GVAX on day 2 of the 6th and 12th booster cycle.
Immune-related Objective Response Rate (irORR)	0 Participants

SECONDARY outcome

Timeframe: 8 weeks

Surgical resectability after neoadjuvant therapy as determined by the number of patients able to undergo surgical resection.

Outcome measures

Outcome measures
Measure	Cyclophosphamide, GVAX, Pembrolizumab and IMC-CS4 n=9 Participants Cyclophosphamide: 200 mg/m\^2, intravenous (IV) infusion GVAX: 5x10\^8 cells, six intradermal (ID) injections Pembrolizumab: 200 mg, intravenous (IV) infusion IMC-CS4: 75 mg (dose level 1) or 100 mg (dose level 2), intravenous (IV) infusion Patients receive neoadjuvant immunotherapy consisting of cyclophosphamide and pembrolizumab on day 1, IMC-CS4 on days 1, 8, and 15, and GVAX on day 2 of Cycles 1 and 2 (3 weeks/cycle). Patients will then undergo pancreaticoduodenectomy 2-3 weeks later, followed by standard of care adjuvant chemotherapy at the discretion of the primary oncologist. Patients may then receive 4 cycles (3 weeks/cycle) of adjuvant immunotherapy (same regimen as Cycles 1 and 2). Disease free patients may receive an additional 12 booster cycles (3 weeks/cycle) of immunotherapy consisting of pembrolizumab on day 1 of all 12 booster cycles, as well as cyclophosphamide on day 1 and GVAX on day 2 of the 6th and 12th booster cycle.
Surgical Resectability Rate	9 Participants

SECONDARY outcome

Timeframe: 8 weeks

Pathologic response as determined by surgical margins status at the time of surgery and response to neoadjuvant treatment per surgical specimen assessment (participants with \<10% residual viable tumor is reported).

Outcome measures

Outcome measures
Measure	Cyclophosphamide, GVAX, Pembrolizumab and IMC-CS4 n=9 Participants Cyclophosphamide: 200 mg/m\^2, intravenous (IV) infusion GVAX: 5x10\^8 cells, six intradermal (ID) injections Pembrolizumab: 200 mg, intravenous (IV) infusion IMC-CS4: 75 mg (dose level 1) or 100 mg (dose level 2), intravenous (IV) infusion Patients receive neoadjuvant immunotherapy consisting of cyclophosphamide and pembrolizumab on day 1, IMC-CS4 on days 1, 8, and 15, and GVAX on day 2 of Cycles 1 and 2 (3 weeks/cycle). Patients will then undergo pancreaticoduodenectomy 2-3 weeks later, followed by standard of care adjuvant chemotherapy at the discretion of the primary oncologist. Patients may then receive 4 cycles (3 weeks/cycle) of adjuvant immunotherapy (same regimen as Cycles 1 and 2). Disease free patients may receive an additional 12 booster cycles (3 weeks/cycle) of immunotherapy consisting of pembrolizumab on day 1 of all 12 booster cycles, as well as cyclophosphamide on day 1 and GVAX on day 2 of the 6th and 12th booster cycle.
Pathologic Response Rate	7 Participants

Adverse Events

Cyclophosphamide, GVAX, Pembrolizumab and IMC-CS4

Serious events: 5 serious events

Other events: 9 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	Cyclophosphamide, GVAX, Pembrolizumab and IMC-CS4 n=9 participants at risk Cyclophosphamide: 200 mg/m\^2, intravenous (IV) infusion GVAX: 5x10\^8 cells, six intradermal (ID) injections Pembrolizumab: 200 mg, intravenous (IV) infusion IMC-CS4: 75 mg (dose level 1) or 100 mg (dose level 2), intravenous (IV) infusion Patients receive neoadjuvant immunotherapy consisting of cyclophosphamide and pembrolizumab on day 1, IMC-CS4 on days 1, 8, and 15, and GVAX on day 2 of Cycles 1 and 2 (3 weeks/cycle). Patients will then undergo pancreaticoduodenectomy 2-3 weeks later, followed by standard of care adjuvant chemotherapy at the discretion of the primary oncologist. Patients may then receive 4 cycles (3 weeks/cycle) of adjuvant immunotherapy (same regimen as Cycles 1 and 2). Disease free patients may receive an additional 12 booster cycles (3 weeks/cycle) of immunotherapy consisting of pembrolizumab on day 1 of all 12 booster cycles, as well as cyclophosphamide on day 1 and GVAX on day 2 of the 6th and 12th booster cycle.
Gastrointestinal disorders Diarrhea	11.1% 1/9 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 25 months. All-cause mortality was evaluated for up to 44 months.
Gastrointestinal disorders Abdominal pain	11.1% 1/9 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 25 months. All-cause mortality was evaluated for up to 44 months.
Investigations Alanine aminotransferase increased	11.1% 1/9 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 25 months. All-cause mortality was evaluated for up to 44 months.
Cardiac disorders Atrial fibrillation	11.1% 1/9 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 25 months. All-cause mortality was evaluated for up to 44 months.
Injury, poisoning and procedural complications Biliary anastomotic leak	11.1% 1/9 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 25 months. All-cause mortality was evaluated for up to 44 months.
General disorders Fever	11.1% 1/9 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 25 months. All-cause mortality was evaluated for up to 44 months.
Infections and infestations Sepsis	11.1% 1/9 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 25 months. All-cause mortality was evaluated for up to 44 months.

Other adverse events

Other adverse events
Measure	Cyclophosphamide, GVAX, Pembrolizumab and IMC-CS4 n=9 participants at risk Cyclophosphamide: 200 mg/m\^2, intravenous (IV) infusion GVAX: 5x10\^8 cells, six intradermal (ID) injections Pembrolizumab: 200 mg, intravenous (IV) infusion IMC-CS4: 75 mg (dose level 1) or 100 mg (dose level 2), intravenous (IV) infusion Patients receive neoadjuvant immunotherapy consisting of cyclophosphamide and pembrolizumab on day 1, IMC-CS4 on days 1, 8, and 15, and GVAX on day 2 of Cycles 1 and 2 (3 weeks/cycle). Patients will then undergo pancreaticoduodenectomy 2-3 weeks later, followed by standard of care adjuvant chemotherapy at the discretion of the primary oncologist. Patients may then receive 4 cycles (3 weeks/cycle) of adjuvant immunotherapy (same regimen as Cycles 1 and 2). Disease free patients may receive an additional 12 booster cycles (3 weeks/cycle) of immunotherapy consisting of pembrolizumab on day 1 of all 12 booster cycles, as well as cyclophosphamide on day 1 and GVAX on day 2 of the 6th and 12th booster cycle.
Investigations Alanine aminotransferase increased	22.2% 2/9 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 25 months. All-cause mortality was evaluated for up to 44 months.
Blood and lymphatic system disorders Anemia	11.1% 1/9 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 25 months. All-cause mortality was evaluated for up to 44 months.
Musculoskeletal and connective tissue disorders Arthralgia	11.1% 1/9 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 25 months. All-cause mortality was evaluated for up to 44 months.
Investigations Aspartate aminotransferase increased	44.4% 4/9 • Number of events 4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 25 months. All-cause mortality was evaluated for up to 44 months.
General disorders Chills	11.1% 1/9 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 25 months. All-cause mortality was evaluated for up to 44 months.
Investigations CPK increased	11.1% 1/9 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 25 months. All-cause mortality was evaluated for up to 44 months.
Gastrointestinal disorders Diarrhea	44.4% 4/9 • Number of events 9 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 25 months. All-cause mortality was evaluated for up to 44 months.
General disorders Fatigue	22.2% 2/9 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 25 months. All-cause mortality was evaluated for up to 44 months.
General disorders Fever	44.4% 4/9 • Number of events 6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 25 months. All-cause mortality was evaluated for up to 44 months.
General disorders Flu like symptoms	11.1% 1/9 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 25 months. All-cause mortality was evaluated for up to 44 months.
Endocrine disorders Hypothyroidism	11.1% 1/9 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 25 months. All-cause mortality was evaluated for up to 44 months.
General disorders Nausea	22.2% 2/9 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 25 months. All-cause mortality was evaluated for up to 44 months.
Skin and subcutaneous tissue disorders Papulopustular rash	11.1% 1/9 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 25 months. All-cause mortality was evaluated for up to 44 months.
Skin and subcutaneous tissue disorders Periorbital edema	33.3% 3/9 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 25 months. All-cause mortality was evaluated for up to 44 months.
Skin and subcutaneous tissue disorders Rash	44.4% 4/9 • Number of events 9 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 25 months. All-cause mortality was evaluated for up to 44 months.
Skin and subcutaneous tissue disorders Vaccine site, bruising	11.1% 1/9 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 25 months. All-cause mortality was evaluated for up to 44 months.
Skin and subcutaneous tissue disorders Vaccine site, erythema	100.0% 9/9 • Number of events 19 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 25 months. All-cause mortality was evaluated for up to 44 months.
Skin and subcutaneous tissue disorders Vaccine site, induration	88.9% 8/9 • Number of events 9 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 25 months. All-cause mortality was evaluated for up to 44 months.
Skin and subcutaneous tissue disorders Vaccine site, pruritus	88.9% 8/9 • Number of events 14 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 25 months. All-cause mortality was evaluated for up to 44 months.
Skin and subcutaneous tissue disorders Vaccine site, warmth	33.3% 3/9 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 25 months. All-cause mortality was evaluated for up to 44 months.
Gastrointestinal disorders Abdominal pain	33.3% 3/9 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 25 months. All-cause mortality was evaluated for up to 44 months.
Musculoskeletal and connective tissue disorders Arthritis	11.1% 1/9 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 25 months. All-cause mortality was evaluated for up to 44 months.
Musculoskeletal and connective tissue disorders Back pain	11.1% 1/9 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 25 months. All-cause mortality was evaluated for up to 44 months.
Injury, poisoning and procedural complications Bruising	22.2% 2/9 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 25 months. All-cause mortality was evaluated for up to 44 months.
Gastrointestinal disorders Constipation	11.1% 1/9 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 25 months. All-cause mortality was evaluated for up to 44 months.
Respiratory, thoracic and mediastinal disorders Cough	11.1% 1/9 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 25 months. All-cause mortality was evaluated for up to 44 months.
Respiratory, thoracic and mediastinal disorders Dyspnea	22.2% 2/9 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 25 months. All-cause mortality was evaluated for up to 44 months.
General disorders Edema face	11.1% 1/9 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 25 months. All-cause mortality was evaluated for up to 44 months.
General disorders Edema limbs	11.1% 1/9 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 25 months. All-cause mortality was evaluated for up to 44 months.
Skin and subcutaneous tissue disorders Erythema multiforme	11.1% 1/9 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 25 months. All-cause mortality was evaluated for up to 44 months.
Gastrointestinal disorders Exocrine insufficiency	11.1% 1/9 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 25 months. All-cause mortality was evaluated for up to 44 months.
Nervous system disorders Headache	22.2% 2/9 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 25 months. All-cause mortality was evaluated for up to 44 months.
Ear and labyrinth disorders Hearing impaired	11.1% 1/9 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 25 months. All-cause mortality was evaluated for up to 44 months.
Vascular disorders Hypertension	22.2% 2/9 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 25 months. All-cause mortality was evaluated for up to 44 months.
Infections and infestations COVID-19 Infection	11.1% 1/9 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 25 months. All-cause mortality was evaluated for up to 44 months.
Psychiatric disorders Insomnia	11.1% 1/9 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 25 months. All-cause mortality was evaluated for up to 44 months.
Respiratory, thoracic and mediastinal disorders Nasal congestion	11.1% 1/9 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 25 months. All-cause mortality was evaluated for up to 44 months.
Gastrointestinal disorders Oral pain	11.1% 1/9 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 25 months. All-cause mortality was evaluated for up to 44 months.
General disorders Pain in the rib cage	11.1% 1/9 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 25 months. All-cause mortality was evaluated for up to 44 months.
Nervous system disorders Peripheral sensory neuropathy	11.1% 1/9 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 25 months. All-cause mortality was evaluated for up to 44 months.
Respiratory, thoracic and mediastinal disorders Productive cough	11.1% 1/9 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 25 months. All-cause mortality was evaluated for up to 44 months.
Infections and infestations Thrush	22.2% 2/9 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 25 months. All-cause mortality was evaluated for up to 44 months.
Gastrointestinal disorders Vomiting	11.1% 1/9 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 25 months. All-cause mortality was evaluated for up to 44 months.
Investigations Weight loss	44.4% 4/9 • Number of events 6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 25 months. All-cause mortality was evaluated for up to 44 months.
Respiratory, thoracic and mediastinal disorders Wheezing	11.1% 1/9 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 25 months. All-cause mortality was evaluated for up to 44 months.

Additional Information

Ana De Jesus-Acosta, MD

SKCCC Johns Hopkins Medical Institution

Phone: 443-287-0411

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place