Participants received an intravenous infusion of avelumab 20mg/kg intervention (IV) once every 2 weeks until confirmed progression, death, unacceptable toxicity, or any criterion for withdrawal occurred.

Duration of response was defined for participants with confirmed objective response (OR), as the time from first documentation of objective response (Complete Response or Partial Response) to the date of first documentation of objective PD or death due to any cause, whichever occurred first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: At least a 20 % increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. DOR was determined according to RECIST v1.1 and assessed by Investigator.

Time to response (TTR) was defined, for participants with an objective response, as the time from the start date of study treatment to the first documentation of OR (CR or PR) which was subsequently confirmed.

Progression-Free survival was defined as the time from first administration of study treatment until the first documentation of disease progression (PD) or death due to any cause, whichever occurred first. PD: At least a 20 % increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. PFS was measured using Kaplan-Meier (KM) estimates.

Overall Survival was defined as the time from date of first dose of study drug to the date of death due to any cause. For participants who were still alive at the time of data analysis or who were lost to follow-up, OS time was censored at the date of last contact. OS was measured using Kaplan-Meier (KM) estimates.

Adverse Event (AE) was defined any untoward medical occurrence in a participant administered with a study drug, which does not necessarily had a causal relationship with this treatment. Serious AE was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs: TEAEs was defined as events with onset date or worsening during the on-treatment period. TEAEs included serious AEs and non-serious AEs. Treatment-related TEAEs: reasonably related to the study intervention. AESIs included Infusion-related reactions (IRRs) and Immune-related AE (irAEs).

The total number of participants with laboratory test abnormalities were assessed. Clinical laboratory tests included hematology and biochemistry abnormalities. The hematology and biochemistry abnormalities (by worst on-treatment NCI-CTCAE Grade 3 and Grade 4) were reported. Laboratory abnormalities were graded using NCI-CTCAE v4.03 toxicity grades, as follows: Grade 1 = Mild, Grade 2= Moderate, Grade 3 = Severe; Grade 4 = Life-threatening and Grade 5 = Death.

Cmax is the maximum observed serum concentration obtained directly from the concentration versus time curve.

Area under the serum concentration-time curve from time zero to the 336 Hours Post-Dose (AUC 0-336 hours) of Avelumab were calculated. Calculated using the mixed loglinear trapezoidal rule (linear up, log down).

Apparent terminal half-life was defined as the time required for the plasma concentration of drug to decrease 50 percent in the final stage of its elimination. Apparent terminal half-life. t1/2 = log (ln) 2/lambdaz (λz).

The concentration observed immediately before next dosing (corresponding to predose or trough concentration for multiple dosing) was calculated.

Serum samples were analyzed by a validated electrochemiluminesce immunoassay to detect the presence of anti-drug antibodies and neutralizing antibodies. Samples that screened positive were subsequently tested in a confirmatory assay. Those confirmed positive were tittered for a quasi-quantitative result. Number of participants with positive treatment emergent anti-drug antibodies and neutralizing antibodies were reported. Participants not positive prior to treatment with avelumab and with at least one positive result in the human-Antihuman Antibodies assay were characterized as treatment-emergent.

Number of participants with positive tumor programmed death ligand 1 (PDL-1) with cut off >=1%, >= 5%, >=25%, >=50% and >=80% expression were reported.

Number of participants with substantial, sustained, or significant changes from baseline for Tumor-Infiltrating T-cell Levels were reported. Significant clinical deterioration (clinical progression), defined as new symptoms that are deemed by the Investigator to be clinically significant or significant worsening of existing symptoms.

Number of participants with substantial, sustained, or significant changes from baseline for T-cell population in blood were reported. Significant clinical deterioration (clinical progression), defined as new symptoms that are deemed by the Investigator to be clinically significant or significant worsening of existing symptoms.

Number of participants with substantial, sustained, or significant changes from baseline for B-cell and NK-cell in blood were reported. Significant clinical deterioration (clinical progression), defined as new symptoms that are deemed by the Investigator to be clinically significant or significant worsening of existing symptoms.

Samples for the testing of vaccination-related antibody concentrations for diphtheria, tetanus, and pneumococcal conjugate (PCV-7) were collected. Significant clinical deterioration (clinical progression), defined as new symptoms that are deemed by the Investigator to be clinically significant or significant worsening of existing symptoms.

Vital signs included: Body temperature, Heart Rate, Blood pressure and respiratory rate. Vital signs were measured in semi-supine position after 5 minutes rest for the participants.

Total of all reporting groups

For the purpose of dose finding, any of the following AEs occurring during the primary DLT observation period. Hematologic: Grade 4 neutropenia for more than 7 days in duration; Grade greater than or equal to (>=) 3 neutropenic infection; Grade >= 3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia > 7 days and Grade 4 anemia. Nonhematologic: Any Grade >= 3 toxicity, except for any of the following: Transient (less than or equal to (<=) 72 hours; Grade 3 flu-like symptoms or fever, which was controlled with medical management; Transient (<= 72 hours) Grade 3 fatigue, local reactions, headache, nausea, or emesis that resolved to Grade <= 1 or to Baseline. Grade 3 diarrhea or Grade 3 skin toxicity that resolved to Grade <= 1 in less than 7 days after medical management (immunosuppressant treatment) had been initiated. Grade >= 3 amylase or lipase abnormality that was not associated with clinical manifestations of pancreatitis.

The DLT analysis set includes all participants who meet either of the following criteria: Have received 100 percent (% ) of all planned doses of treatment during the DLT evaluation period (first 2 cycles of treatment) and have been followed for at least 28 days or have stopped treatment because of a DLT in the DLT evaluation period.

Confirmed BOR was evaluated based on RECIST v1.1 and Investigator's assessments and defined as best response of any of confirmed complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from date of study treatment until disease progression. CR: Disappearance of all evidence of target/non-target lesions. PR: At least 30 percent (%) reduction from baseline in sum of longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD: at least a 20% increase in SLD, taking as reference smallest SLD recorded from baseline/appearance of 1or more new lesions and unequivocal progression of non-target lesions.

Full analysis set included all participants who received any dose of avelumab.

Duration of response was defined for participants with confirmed objective response (OR), as the time from first documentation of objective response (Complete Response or Partial Response) to the date of first documentation of objective PD or death due to any cause, whichever occurred first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: At least a 20 % increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. DOR was determined according to RECIST v1.1 and assessed by Investigator.

Data could not be calculated as none of the participants showed objective response.

Time to response (TTR) was defined, for participants with an objective response, as the time from the start date of study treatment to the first documentation of OR (CR or PR) which was subsequently confirmed.

Data could not be calculated as none of the participants showed confirmed objective response.

Progression-Free survival was defined as the time from first administration of study treatment until the first documentation of disease progression (PD) or death due to any cause, whichever occurred first. PD: At least a 20 % increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. PFS was measured using Kaplan-Meier (KM) estimates.

Full analysis set included all participants who received any dose of avelumab. Here, "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

Overall Survival was defined as the time from date of first dose of study drug to the date of death due to any cause. For participants who were still alive at the time of data analysis or who were lost to follow-up, OS time was censored at the date of last contact. OS was measured using Kaplan-Meier (KM) estimates.

Full analysis set included all participants who received any dose of avelumab. Here, "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

Adverse Event (AE) was defined any untoward medical occurrence in a participant administered with a study drug, which does not necessarily had a causal relationship with this treatment. Serious AE was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs: TEAEs was defined as events with onset date or worsening during the on-treatment period. TEAEs included serious AEs and non-serious AEs. Treatment-related TEAEs: reasonably related to the study intervention. AESIs included Infusion-related reactions (IRRs) and Immune-related AE (irAEs).

The safety analysis set included all participants who received any dose of avelumab.

The total number of participants with laboratory test abnormalities were assessed. Clinical laboratory tests included hematology and biochemistry abnormalities. The hematology and biochemistry abnormalities (by worst on-treatment NCI-CTCAE Grade 3 and Grade 4) were reported. Laboratory abnormalities were graded using NCI-CTCAE v4.03 toxicity grades, as follows: Grade 1 = Mild, Grade 2= Moderate, Grade 3 = Severe; Grade 4 = Life-threatening and Grade 5 = Death.

Safety analysis set included all participants who received any dose of avelumab.

Cmax is the maximum observed serum concentration obtained directly from the concentration versus time curve.

The Pharmacokinetic (PK) analysis set included all participants who received at least one dose of avelumab, had no important protocol deviations or important events affecting PK, and provided at least one measurable post-dose concentration.

Area under the serum concentration-time curve from time zero to the 336 Hours Post-Dose (AUC 0-336 hours) of Avelumab were calculated. Calculated using the mixed loglinear trapezoidal rule (linear up, log down).

The PK analysis set included all particpants who received at least one dose of avelumab, had no important protocol deviations or important events affecting PK, and provided at least one measurable post-dose concentration. Here" number of participants analyzed" are those who are evaluable for this outcome measure.

Apparent terminal half-life was defined as the time required for the plasma concentration of drug to decrease 50 percent in the final stage of its elimination. Apparent terminal half-life. t1/2 = log (ln) 2/lambdaz (λz).

The PK analysis set included all participants who received at least one dose of avelumab, had no important protocol deviations or important events affecting PK, and provided at least one measurable post-dose concentration. Here, "Number of participants analyzed" are those who are evaluable for this outcome measure.

The concentration observed immediately before next dosing (corresponding to predose or trough concentration for multiple dosing) was calculated.

The PK analysis set included all participants who received at least one dose of avelumab, had no important protocol deviations or important events affecting PK, and provided at least one measurable post-dose concentration.

Serum samples were analyzed by a validated electrochemiluminesce immunoassay to detect the presence of anti-drug antibodies and neutralizing antibodies. Samples that screened positive were subsequently tested in a confirmatory assay. Those confirmed positive were tittered for a quasi-quantitative result. Number of participants with positive treatment emergent anti-drug antibodies and neutralizing antibodies were reported. Participants not positive prior to treatment with avelumab and with at least one positive result in the human-Antihuman Antibodies assay were characterized as treatment-emergent.

Immunogenicity Analysis Set included all partiicpants who received any dose of avelumab and have at least one valid ADA result.

Number of participants with positive tumor programmed death ligand 1 (PDL-1) with cut off >=1%, >= 5%, >=25%, >=50% and >=80% expression were reported.

Biomarker Analysis Set included all participants who received any dose of avelumab and who have provided at least one blood, serum, plasma, or tumor sample for biomarker assessments.

Number of participants with substantial, sustained, or significant changes from baseline for Tumor-Infiltrating T-cell Levels were reported. Significant clinical deterioration (clinical progression), defined as new symptoms that are deemed by the Investigator to be clinically significant or significant worsening of existing symptoms.

Since all evaluable tumor tissue samples were collected at baseline and no evaluable sample was provided at end of treatment as planned, an analysis of participants with substantial, sustained, or significant changes from baseline for tumor-infiltrating T-cell levels could not be performed.

Number of participants with substantial, sustained, or significant changes from baseline for T-cell population in blood were reported. Significant clinical deterioration (clinical progression), defined as new symptoms that are deemed by the Investigator to be clinically significant or significant worsening of existing symptoms.

Due to early termination of the study, the data for this outcome measure was not collected.

Number of participants with substantial, sustained, or significant changes from baseline for B-cell and NK-cell in blood were reported. Significant clinical deterioration (clinical progression), defined as new symptoms that are deemed by the Investigator to be clinically significant or significant worsening of existing symptoms.

Due to early termination of the study, the data for this outcome measure was not collected.

Samples for the testing of vaccination-related antibody concentrations for diphtheria, tetanus, and pneumococcal conjugate (PCV-7) were collected. Significant clinical deterioration (clinical progression), defined as new symptoms that are deemed by the Investigator to be clinically significant or significant worsening of existing symptoms.

Due to early termination of the study, the data for this outcome measure was not collected.

Vital signs included: Body temperature, Heart Rate, Blood pressure and respiratory rate. Vital signs were measured in semi-supine position after 5 minutes rest for the participants.

The safety analysis set included all participants who received any dose of avelumab.

Participants received an intravenous infusion of avelumab 20 mg/kg IV once every 2 weeks until confirmed progression, death, unacceptable toxicity, or any criterion for withdrawal occurred.