Trial Outcomes & Findings for Study of Glembatumumab Vedotin (CDX-011) in Patients With Metastatic, gpNMB Over-Expressing, Triple Negative Breast Cancer (NCT NCT01997333)

NCT ID: NCT01997333

Last Updated: 2019-03-08

Results Overview

PFS is defined as the time from randomization to the earlier of disease progression or death due to any cause. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or progression in a non-target lesion, or the appearance of new lesions. The primary analysis of PFS was based on PFS events determined retrospectively by the central independent review committee, blinded to treatment assignment and investigator assessments according to RECIST 1.1 criteria.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

327 participants

Primary outcome timeframe

Evaluated every 6 - 9 weeks following treatment initiation

Results posted on

2019-03-08

Participant Flow

1531 patients screened to randomize 327 patients. Most common reasons for screen failure were tumor tissue inadequate/gpNMB negative (697), failure to meet other eligibility (256) and refused to participate (77).

Participant milestones

Participant milestones
Measure	Capecitabine Capecitabine administered on Days 1 through 14 of each 21 day cycle until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study.	CDX-011 CDX-011 administered on Day 1 of each 21 day cycle until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study.
Randomization and Treatment STARTED	109	218
Randomization and Treatment COMPLETED	6	15
Randomization and Treatment NOT COMPLETED	103	203
Survival Follow up STARTED	92	213
Survival Follow up COMPLETED	76	199
Survival Follow up NOT COMPLETED	16	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Capecitabine Capecitabine administered on Days 1 through 14 of each 21 day cycle until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study.	CDX-011 CDX-011 administered on Day 1 of each 21 day cycle until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study.
Randomization and Treatment Disease Progression	70	159
Randomization and Treatment Adverse Event	10	32
Randomization and Treatment Physician Decision	0	4
Randomization and Treatment Withdrawal by Subject	6	3
Randomization and Treatment Did not receive treatment	17	5
Survival Follow up Withdrawal by Subject	15	6
Survival Follow up Lost to Follow-up	0	6
Survival Follow up Various	1	2

Baseline Characteristics

Study of Glembatumumab Vedotin (CDX-011) in Patients With Metastatic, gpNMB Over-Expressing, Triple Negative Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Capecitabine n=109 Participants Capecitabine administered on Days 1 through 14 of each 21 day cycle until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study.	CDX-011 n=218 Participants CDX-011 administered on Day 1 of each 21 day cycle until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study.	Total n=327 Participants Total of all reporting groups
Age, Continuous	55 years n=5 Participants	55 years n=7 Participants	55 years n=5 Participants
Sex: Female, Male Female	109 Participants n=5 Participants	218 Participants n=7 Participants	327 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	11 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	99 Participants n=5 Participants	191 Participants n=7 Participants	290 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	16 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	20 Participants n=7 Participants	29 Participants n=5 Participants
Race (NIH/OMB) White	91 Participants n=5 Participants	176 Participants n=7 Participants	267 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	16 Participants n=7 Participants	23 Participants n=5 Participants
Region of Enrollment Canada	7 participants n=5 Participants	5 participants n=7 Participants	12 participants n=5 Participants
Region of Enrollment Belgium	2 participants n=5 Participants	6 participants n=7 Participants	8 participants n=5 Participants
Region of Enrollment United States	72 participants n=5 Participants	143 participants n=7 Participants	215 participants n=5 Participants
Region of Enrollment Italy	6 participants n=5 Participants	7 participants n=7 Participants	13 participants n=5 Participants
Region of Enrollment United Kingdom	5 participants n=5 Participants	6 participants n=7 Participants	11 participants n=5 Participants
Region of Enrollment Australia	3 participants n=5 Participants	15 participants n=7 Participants	18 participants n=5 Participants
Region of Enrollment France	4 participants n=5 Participants	14 participants n=7 Participants	18 participants n=5 Participants
Region of Enrollment Germany	5 participants n=5 Participants	9 participants n=7 Participants	14 participants n=5 Participants
Region of Enrollment Spain	5 participants n=5 Participants	13 participants n=7 Participants	18 participants n=5 Participants
Number of prior relapses in advanced stage 0	21 participants n=5 Participants	45 participants n=7 Participants	66 participants n=5 Participants
Number of prior relapses in advanced stage 1	58 participants n=5 Participants	122 participants n=7 Participants	180 participants n=5 Participants
Number of prior relapses in advanced stage 2	24 participants n=5 Participants	42 participants n=7 Participants	66 participants n=5 Participants
Number of prior relapses in advanced stage 3	6 participants n=5 Participants	9 participants n=7 Participants	15 participants n=5 Participants
Number of cytotoxic regimens in advanced stage	1 cytotoxic regimen n=5 Participants	1 cytotoxic regimen n=7 Participants	1 cytotoxic regimen n=5 Participants
Prior Taxane Use	108 Participants n=5 Participants	218 Participants n=7 Participants	326 Participants n=5 Participants
Prior Anthracycline Use	95 Participants n=5 Participants	185 Participants n=7 Participants	280 Participants n=5 Participants
Progression Free Interval post last Taxane less than or equal to 6 months	51 Participants n=5 Participants	112 Participants n=7 Participants	163 Participants n=5 Participants
Progression Free Interval post last Taxane greater than 6 months	58 Participants n=5 Participants	106 Participants n=7 Participants	164 Participants n=5 Participants

PRIMARY outcome

Timeframe: Evaluated every 6 - 9 weeks following treatment initiation

Outcome measures

Outcome measures
Measure	Capecitabine n=109 Participants Capecitabine administered on Days 1 through 14 of each 21 day cycle until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study.	CDX-011 n=218 Participants CDX-011 administered on Day 1 of each 21 day cycle until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study.
Progression Free Survival (PFS)	2.8 months Interval 1.6 to 3.2	2.9 months Interval 2.8 to 3.5

SECONDARY outcome

Timeframe: Evaluated every 6 - 9 weeks following treatment initiation

Population: Patients with measurable disease.

ORR is defined as the percentage of patients who achieve best overall response of complete or partial response. The analysis of ORR was based on ORR events determined retrospectively by the central independent review committee, blinded to treatment assignment and investigator assessments according to RECIST 1.1 criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), Complete Response (CR) = Disappearance of all target lesions and non-target lesions, Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions with no progression in non-target lesions and no new lesions.

Outcome measures

Outcome measures
Measure	Capecitabine n=100 Participants Capecitabine administered on Days 1 through 14 of each 21 day cycle until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study.	CDX-011 n=179 Participants CDX-011 administered on Day 1 of each 21 day cycle until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study.
Objective Response Rate (ORR)	21 percentage of participants Interval 14.0 to 30.0	26 percentage of participants Interval 20.0 to 33.0

SECONDARY outcome

Timeframe: Evaluated every 6 - 9 weeks following treatment initiation

Duration of response (DOR) is the number of months from the time criteria are first met for either CR or PR, until the first date that PD is objectively documented. The analysis of DOR was determined retrospectively by the central independent review committee,blinded to treatment assignment and investigator assessments according to RECIST 1.1 criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), Complete Response (CR) = Disappearance of all target lesions and non-target lesions, Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions with no progression in non-target lesions and no new lesions.

Outcome measures

Outcome measures
Measure	Capecitabine n=21 Participants Capecitabine administered on Days 1 through 14 of each 21 day cycle until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study.	CDX-011 n=46 Participants CDX-011 administered on Day 1 of each 21 day cycle until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study.
Duration of Response	4.2 months Interval 2.7 to 5.6	2.8 months Interval 2.3 to 5.5

SECONDARY outcome

Timeframe: During treatment and 3 months from end of treatment through end of study or approximately up to 5 years.

Overall Survival (OS) is defined as the number of months from randomization to the date of death due to any cause.

Outcome measures

Outcome measures
Measure	Capecitabine n=109 Participants Capecitabine administered on Days 1 through 14 of each 21 day cycle until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study.	CDX-011 n=218 Participants CDX-011 administered on Day 1 of each 21 day cycle until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study.
Overall Survival	8.7 months Interval 6.9 to 10.8	8.9 months Interval 7.9 to 10.5

SECONDARY outcome

Timeframe: Usually following at least 1 cycle of study treatment (1 dose of CDX-011 or capecitabine and until discontinuation of follow-up)

The percentage of patients experiencing one or more adverse events will be summarized by treatment arm, relationship to study drug, and severity.

Outcome measures

Outcome measures
Measure	Capecitabine n=92 Participants Capecitabine administered on Days 1 through 14 of each 21 day cycle until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study.	CDX-011 n=213 Participants CDX-011 administered on Day 1 of each 21 day cycle until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study.
Adverse Events (AE) Patients with at least 1 AE	92 Participants	211 Participants
Adverse Events (AE) Patients with at least 1 treatment related AE	84 Participants	204 Participants
Adverse Events (AE) Patients with Grade 1 treatment related AE	7 Participants	7 Participants
Adverse Events (AE) Patients with Grade 2 treatment related AE	33 Participants	54 Participants
Adverse Events (AE) Patients with Grade 3 treatment related AE	44 Participants	114 Participants
Adverse Events (AE) Patients with Grade 4 treatment related AE	8 Participants	32 Participants
Adverse Events (AE) Patients with Grade 5 treatment related AE	0 Participants	4 Participants

SECONDARY outcome

Timeframe: Following 1 dose of CDX-011.

Population: Samples were obtained from 201 of 213 patients treated with CDX-011. A partial analysis provided below results. Additional analyses were not completed. Results should be interpreted with caution.

Concentration of the antibody drug conjugate (ADC), total antibody (TA) and free MMAE will be determined.

Outcome measures

Outcome measures
Measure	Capecitabine n=201 Participants Capecitabine administered on Days 1 through 14 of each 21 day cycle until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study.	CDX-011 CDX-011 administered on Day 1 of each 21 day cycle until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study.
Pharmacokinetics (PK) Cycle 1 post infusion ADC levels	58.6 ug/ml Interval 38.8 to 98.3	—
Pharmacokinetics (PK) Cycle 1 post infusion TA levels	49.4 ug/ml Interval 21.4 to 127.4	—
Pharmacokinetics (PK) Cycle 1 post infusion MMAE levels	0.0015 ug/ml Interval 0.0004 to 0.005	—

Adverse Events

Capecitabine

Serious events: 19 serious events

Other events: 91 other events

Deaths: 65 deaths

CDX-011

Serious events: 71 serious events

Other events: 211 other events

Deaths: 134 deaths

Serious adverse events

Other adverse events

Additional Information

Head of Regulatory Affairs

Celldex Therapeutics

Phone: 844-723-9363

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Capecitabine n=92 participants at risk Capecitabine administered on Days 1 through 14 of each 21 day cycle until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study.	CDX-011 n=213 participants at risk CDX-011 administered on Day 1 of each 21 day cycle until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study.
Investigations Blood bilirubin increased	0.00% 0/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	0.47% 1/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Investigations Blood creatinine increased	0.00% 0/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	0.47% 1/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Investigations Weight decreased	0.00% 0/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	0.47% 1/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Investigations White blood cell count decreased	0.00% 0/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	0.47% 1/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Metabolism and nutrition disorders Decreased appetite	1.1% 1/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	0.47% 1/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Metabolism and nutrition disorders Dehydration	2.2% 2/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	1.4% 3/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Metabolism and nutrition disorders Electrolyte imbalance	0.00% 0/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	0.47% 1/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	0.47% 1/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	0.47% 1/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	0.94% 2/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Metabolism and nutrition disorders Hyponatraemia	1.1% 1/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	0.00% 0/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	0.94% 2/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Musculoskeletal and connective tissue disorders Back pain	1.1% 1/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	0.94% 2/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Musculoskeletal and connective tissue disorders Bone pain	1.1% 1/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	0.47% 1/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Musculoskeletal and connective tissue disorders Chest wall mass	0.00% 0/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	0.47% 1/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Musculoskeletal and connective tissue disorders Muscular weakness	1.1% 1/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	0.00% 0/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	1.1% 1/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	0.00% 0/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Musculoskeletal and connective tissue disorders Pain in extremity	1.1% 1/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	0.94% 2/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	0.47% 1/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to meninges	0.00% 0/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	0.47% 1/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Nervous system disorders Brain oedema	1.1% 1/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	0.00% 0/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Nervous system disorders Dysarthria	0.00% 0/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	0.94% 2/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Nervous system disorders Headache	0.00% 0/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	0.94% 2/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Nervous system disorders Hepatic encephalopathy	0.00% 0/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	0.47% 1/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Nervous system disorders Peripheral motor neuropathy	1.1% 1/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	0.00% 0/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Psychiatric disorders Anxiety	0.00% 0/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	0.94% 2/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Psychiatric disorders Hallucination	1.1% 1/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	0.47% 1/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Psychiatric disorders Mental status changes	1.1% 1/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	0.00% 0/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Renal and urinary disorders Proteinuria	0.00% 0/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	0.47% 1/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Reproductive system and breast disorders Breast pain	1.1% 1/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	0.00% 0/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	2.8% 6/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	0.47% 1/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	0.47% 1/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Respiratory, thoracic and mediastinal disorders Pharyngeal oedema	0.00% 0/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	0.47% 1/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.2% 2/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	1.4% 3/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	0.47% 1/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.2% 2/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	0.94% 2/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	0.47% 1/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	0.47% 1/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Skin and subcutaneous tissue disorders Erthyema	0.00% 0/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	0.47% 1/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.

Other adverse events
Measure	Capecitabine n=92 participants at risk Capecitabine administered on Days 1 through 14 of each 21 day cycle until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study.	CDX-011 n=213 participants at risk CDX-011 administered on Day 1 of each 21 day cycle until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study.
Investigations Asparate aminotransferase increased	6.5% 6/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	11.7% 25/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Investigations Blood alkaline phosphotase increased	2.2% 2/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	8.5% 18/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Investigations Lymphocyte count decreased	3.3% 3/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	5.6% 12/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Blood and lymphatic system disorders Anaemia	9.8% 9/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	15.5% 33/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Blood and lymphatic system disorders Neutropenia	5.4% 5/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	23.0% 49/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Gastrointestinal disorders Abdominal distension	3.3% 3/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	5.6% 12/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Gastrointestinal disorders Abdominal pain	17.4% 16/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	10.3% 22/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Gastrointestinal disorders Abdominal pain upper	6.5% 6/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	8.0% 17/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Gastrointestinal disorders Constipation	14.1% 13/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	28.6% 61/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Gastrointestinal disorders Diarrhoea	47.8% 44/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	25.8% 55/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Gastrointestinal disorders Dyspepsia	4.3% 4/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	10.3% 22/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Gastrointestinal disorders Dysphagia	0.00% 0/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	5.6% 12/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Gastrointestinal disorders Gastrooesophageal reflux disease	4.3% 4/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	7.5% 16/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Gastrointestinal disorders Nausea	42.4% 39/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	42.7% 91/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Gastrointestinal disorders Oral pain	2.2% 2/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	5.2% 11/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Gastrointestinal disorders Stomatitis	26.1% 24/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	17.4% 37/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Gastrointestinal disorders Vomiting	18.5% 17/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	21.6% 46/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
General disorders Asthenia	5.4% 5/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	6.6% 14/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
General disorders Chills	4.3% 4/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	6.6% 14/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
General disorders Fatigue	40.2% 37/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	47.4% 101/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
General disorders Non-cardiac chest pain	5.4% 5/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	1.9% 4/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
General disorders Oedema peripheral	10.9% 10/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	6.1% 13/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
General disorders Pain	4.3% 4/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	9.9% 21/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
General disorders Pyrexia	13.0% 12/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	17.4% 37/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Infections and infestations Oral candidiasis	1.1% 1/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	8.5% 18/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Infections and infestations Urinary tract infection	3.3% 3/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	8.5% 18/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Investigations Alanine aminotransferase increased	3.3% 3/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	10.8% 23/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Investigations Neutrophil count decreased	1.1% 1/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	17.8% 38/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Investigations Weight decreased	5.4% 5/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	17.4% 37/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Investigations White blood cell count decreased	2.2% 2/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	11.3% 24/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Metabolism and nutrition disorders Decreased appetite	18.5% 17/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	29.6% 63/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Metabolism and nutrition disorders Dehydration	6.5% 6/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	7.0% 15/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	7.0% 15/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Metabolism and nutrition disorders Hypoalbuminaemia	5.4% 5/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	5.2% 11/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Metabolism and nutrition disorders Hypokalaemia	8.7% 8/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	11.3% 24/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Metabolism and nutrition disorders Hypophosphataemia	5.4% 5/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	6.6% 14/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Musculoskeletal and connective tissue disorders Arthralgia	3.3% 3/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	17.8% 38/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Musculoskeletal and connective tissue disorders Back pain	13.0% 12/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	9.9% 21/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Musculoskeletal and connective tissue disorders Bone pain	3.3% 3/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	11.3% 24/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Musculoskeletal and connective tissue disorders Muscle spasms	1.1% 1/92 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.	5.6% 12/213 • Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.